Quality Systems Specialist Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the quality systems specialist job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

A Smith

Arianna

Smith

657 Keeling Place

Chicago

+1 (555) 886 7956

657 Keeling Place

Chicago

Phone

p +1 (555) 886 7956

Experience Experience

Philadelphia, PA

Quality Systems Specialist

Philadelphia, PA

Will-Medhurst

Philadelphia, PA

Quality Systems Specialist

Speaking and writing in the Dutch language is mandatory
Participating in the approval, oversight and performance management of contracted MROs (Maintenance, Repair & Overhaul)
Training senior management on preparation for third party audits
Working under minimal direction
Conducting regular independent audits in order to proactively identify non-compliances and areas for improvement
Providing comprehensive assessment of all activities that ensure continued airworthiness of customer aircraft
Ensuring adequate corrective and/or preventative actions are implemented, planned or accomplished for all audit findings

Boston, MA

Senior Quality Systems Specialist

Boston, MA

Price-Donnelly

Boston, MA

Senior Quality Systems Specialist

Lead the establishment of standardized methods of training across the site using a diverse range of training materials
Site audit prep activities. Assist in mobilizing the site ensuring everyone and everything is ready for audit
Provision of monitoring and trending metrics associated with site quality systems
Demonstrates good judgment in selecting methods and techniques for obtaining solutions
Provide ongoing advice, guidance and support to customers on the process and the use of the supporting Software
Monitor system use for Documentation and Training; ensure timely preparation of trend reports for customer use and management reporting
Responsible for review and approval of the following types of documents, relating to area functions

present

Boston, MA

Senior Quality Systems Specialist Computer Systems

Boston, MA

Hansen, Schultz and Leannon

present

Boston, MA

Senior Quality Systems Specialist Computer Systems

present

Perform and close out audits of computer system, software and service suppliers based on recommendations in a timely manner
Provide technical guidance and supervision to computer system validation engineers at multiple B. Braun U.S. facilities
Quality Risk Management process and tools
Supervise and otherwise manage personnel and contractors involved in computer and control system validation
Thorough knowledge of management principles and supervisory practices
Author and implement corporate and local policies and procedures pertaining to computer system validation and change control
Interface with personnel both within and outside department, external contractors/consultants, customers and government agencies

Education Education

Bachelor’s Degree in Scientific

University of California, Berkeley

Bachelor’s Degree in Scientific

Skills Skills

Good knowledge of quality certifications like HACCP, BRC, ISO, etc
Understands and applies good working knowledge of quality and GMP principles
Basic understanding of GMP and quality system standards desirable
Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines
Strong food industry experience managing people coupled with strong supplier quality related experience in the food industry
Strong knowledge of Quality methodology
Thorough knowledge of quality related metrics and processes for hardware and software products
Ability to handle multiple tasks simultaneously while maintaining attention to detail
Strong self-motivation and ability to work under limited supervision
Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment

Create a Resume in Minutes

15 Quality Systems Specialist resume templates

Read our complete resume writing guides

Quality Systems Specialist Resume Examples & Samples

Support, implementation, and maintenance of all internal quality system requirements including Layered Process Audits, TPM, Magna GQS, and Magna MAFACT
Proactively identify industry regulatory compliance trends in order to close any gaps within the Quality System
Identify, support, and develop departmental resources to achieve business and quality objectives, while remaining compliant to the Quality System(s)
Maintain internal corrective action database to ensure timely closure of quality system non-conformances
Extensive experience in automotive quality systems and related documentation
In depth knowledge of TS16949:2009 and/or VDA 6.1auditing processes and procedures
Working knowledge of automotive problem solving methodologies
Must be very detail oriented
Lead Auditor Certification preferred (not required)
Experience in APQP (Advance Product Quality Planning) and PPAP (Production Part Approval Process)
Must be self-motivated and be able to work without direct supervision
Associates degree and 5+ years’ experience in automotive quality systems preferred

Quality Systems Specialist Resume Examples & Samples

College degree preferred with at least 2 years relevant experience
Experience with Quality Systems required
Change Control experience preferred
CAPA, Deviation, and TrackWise experience a plus
Ability to speak effectively and communicate directly with all levels of personnel in a global environment
Ability to write routine reports and correspondence for internal and external customer communications
Computer literate—experience with Microsoft Office and TrackWise preferred
Strong leadership capabilities and ability to drive compliance
Contribute to a team-oriented environment
Effectively communicate with all departments within Shire

Advanced Quality Systems Specialist Resume Examples & Samples

Coordinate review of proposals/quality plans with cognizant units to determine terms are in accordance with Company commitments and responsive to customer requirements
Maintain lines of communication with customer, and as required, negotiate Quality terms & conditions
Ensure contract / regulatory requirements are flowed down to and understood by responsible units via applicable policies/procedures
Plan, identify and resolve gaps to Quality System, working with customers, suppliers, subject matter experts, and Program Quality
Procurement

Medical Quality Systems Specialist Resume Examples & Samples

Writes and maintains applicable procedures, work instructions and forms
Monitors the Quality Management System for effectiveness, opportunities for improvement and risk
Performs CAPA and NCMR process management
Ensures implementation of regulatory requirements into Quality Management System processes
Documents compliant investigations and maintains document controls
Tracks and reports quality related metrics
Supports QA review and approval of design and validation documents
Maintains FDA annual registration and device listing
Develops key metrics, processes, internal control evaluation, document control and management reviews in compliance with quality standards and regulations
Evaluates deficiencies in current processes and recommends changes to remedy problems
Facilities internal training on quality assurance requirements, processes and procedures
Performs internal and external audits and risk assessments as needed
May be assigned additional duties and/or special projects
Requires a Bachelor’s degree in a related field and 2-5 years’ experience in a quality assurance or regulatory affairs role in a FDA regulated environment
Working knowledge of FDA Quality System Regulations 21 CFR Part 820 and Part 11, ISO 13485:2012, Health Canadaand European Medical Device Directives
Certified Lead or ASQ Auditor a plus
Strong computer, written and interpersonal skills

Quality Systems Specialist Resume Examples & Samples

Prepares audit and product evaluation schedules. Documents conclusion and follows up regarding countermeasure implementation
Leads quality meetings for countermeasure discussion and implementation. Tracks completion of action items and monitors effectiveness of countermeasures
Monitors the effectiveness of various processes through use of data and internal auditing programs
Reviews and analyzes data/reports for accuracy and provides feedback. Provides statistical analysis and makes decision based on collected data
Leads approval meetings for each phase of production startup and develops project schedule with other departments
Monitors and tracks manufacturing data using statistical analysis to ensure process is capable. Provides sampling reduction plan based on process capability
Leads quality improvement meetings and ensures team members are meeting deadlines
Utilizes past test reports to develop complex test plan/matrix
Performs annual review of departmental procedures
Provides training to less experienced members
Performs media feed, image and physical properties evaluation tests following quality specifications
Performs tests in varying environmental conditions for compatibility, product investigation, and final evaluation
Recommends or rejects test media based on test results data and history of the media
Reviews and approves media evaluation data from test
Creates media guides and data sheets for various Canon copiers/printers
Installs and calibrates new equipment. Performs trouble shooting of existing equipment. Contacts and schedules technician for major troubleshooting/repairs to equipment
Orders and replaces consumable items needed for testing. Replaces consumables on copier and/or printer test equipment as needed
Benchmarks other organizations media materials, equipment, and process to compare to CVI
Develops proposals and specifications for new production evaluation
Any combination of education and experience equivalent to a Bachelor’s degree and 8-12 years experience in a quality environment
Proficient in Microsoft Office, Quick Place, Proquis, and Oracle
Experience implementing quality systems in a manufacturing environment preferred

Quality Systems Specialist Resume Examples & Samples

Ensures the organization is adhering to established quality standards through development of key metrics, processes, internal controls evaluation, document control and management reviews in compliance with quality standards including 21 CFR 820 (QSR), ISO 13485 and other FDA and International (EU, Canada) regulations
Assists in the development of regulatory compliant Quality Management System processes and procedure.s
Provide daily Quality support for Assay manufacturing, QC, and Validation
Generates tracks and monitors closeout of key Quality System records including Non-Conformance Reports, CAPA, Audit Reports, and Supplier Quality Records
Reviews/audits Quality System records including batch production records, product inspection and test records and executed validation protocols for conformance to applicable internal procedures and regulatory requirements
Conducts internal quality audits of the organization to verify adherence to internal procedures and compliance with regulatory requirements
Facilitates internal training on Quality System requirements, processes, and procedures
Collaborates with other departments and cross-functional teams on daily tasks and projects
Performs risk assessments when necessary
Assists in preparation for and support of Quality System inspections by external agencies
Education Required: Bachelor's Degree, preferably in a science or health related field
Experience Required: 3+ years' experience in a quality or regulatory role in an FDA regulated environment. Medical Device/IVD experience strongly preferred. Quality Auditor certification preferred
Proven ability to identify and implement requirements of the FDA QSR regulation is required
Requires knowledge of regulations in the field of medical devices, in-vitro diagnostics, molecular diagnostics or related industry e.g. ISO 13485, 21 CFR Parts 820 and 11; CE Marking requirements
Experience in Quality System development and implementation projects, including writing, developing, and implementing policies and procedures
Experience conducting quality audits to FDA and industry standards, including development, documentation and implementation of corrective/preventive action responses
Demonstrated ability to take initiative and provide solutions for improvement
Proven ability to successfully develop and deliver training programs to audiences of varying skill levels
Strong overall computer skills and prior experience with applications used in Quality Systems; e.g., applications for document control, test management, and monitoring corrective actions
Strong customer service orientation, with a focus on delivering quality results
Ability to organize and prioritize; flexible with ability to manage multiple duties and tasks

Quality Systems Specialist Auditor Resume Examples & Samples

Mature the Fleet Management Organisation - Safety Management System
Ideally educated to a degree level or similar
Extensive knowledge of Regulations (Part 145, Part M, Part 21, Part 147, Part 66 and FAA) required
Preferred experience within a Continuing Airworthiness Management Organisation
Familiar with Continuing Airworthiness Records Systems (e.g. AMOS, SAP, Mxi….)
Lead Auditor Trained to recognised standard (e.g. IRCA, AS9100
Experience in the use of auditing applications (e.g. Q-Pulse, AQD…)
Experienced in Incident Investigation techniques e.g. MEDA principles
Familiar with concept of Continuous Improvement e.g. Lean +

Quality Systems Specialist Resume Examples & Samples

Reviews proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development
Assures program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Identifies root cause of problems
Uses statistical methods and quality tools to continuously improve process capability
Conducts quality source selection and process reviews of suppliers' ability to meet program quality requirements and support business decisions
Conducts hardware, tooling and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements
Analyzes data to provide material review dispositions for nonconforming materials, parts and equipment
Ability to identify root causes of problems
Has participated with stakeholders to develop potential preventive or corrective actions and implementation

Senior Quality Systems Specialist Resume Examples & Samples

Knowledge of FDA regulations (21 Part 820), ISO 13485, and Medtronic quality requirements associated with CAPA
Influence management skills; ability to work constructively across all functions of the organization and build relationships
Strong technical writing and documentation review skills. Ability to develop and deliver presentations
Experience with quality tools and process improvement techniques
Knowledge of Neuromodulation products, technologies and therapies

Senior Quality Systems Specialist Resume Examples & Samples

Very strong communication skills, both oral and written including demonstrated experience working directly with a senior leadership team
In depth knowledge of ISO,FDA, and other Quality System Requirements
Proficient working with electronic records databases as well as Microsoft Office and Minitab
Experience working in a highly regulated industry, preferrable implantable and single use medical devices
Ability to work in a constantly-changing, fast-paced environment
Very strong organizational, process and project management skills; proven ability to drive and champion organizational change programs
May involve up to 5% travel
5+ years in a regulated environment
Master's degree in Medical Device, Science, or Engineering field
Certification as a Quality Engineer, ASQ Auditor, and ISO Assessor highly desired
Understanding of DMAIC, and Lean principles
Demonstrated ability to learn new software systems to perform basic functions (e.g. routing records for approval in electronic records repositories, filtering data in analytics software)
Highly developed influence management skills, including the proven ability to organize, communicate, and manage issues to a variety of levels of individuals within the organization
Eagerness to learn and expand responsibilities
Ability to work effectively in a team environment in a leadership capacity and build strong working relationships, involving multiple business functions, units, and/or geographies

Quality Systems Specialist Resume Examples & Samples

Bachelor’s degree and 3+ years’ of experience with configuration management, document control, process improvement and project management, database administration processes, or similar activities, in a regulated or highly structured environment (e.g., medical device, aerospace, automotive, military) or Masters Degree and 2+ years’ of experience with configuration management, document control, process improvement and project management, database administration processes, or similar activities, in a regulated or highly structured environment (e.g., medical device, aerospace, automotive, military)
Familiarity with modern ERP systems, PLM systems and/or manufacturing documentation (i.e., parts, BOMs, item masters)
Demonstrated track record of understanding and applying FDA’s Quality System Regulation and/or ISO 13485 requirements for quality management systems, including supporting CAPA investigations or related activities in other regulated environments
Ability to communicate in writing clearly and concisely, using excellent grammar and sentence structure
Completion of an appropriate certification program for Configuration Management
Highly capable of attention to detail and accuracy
Ability to effectively manage multiple projects and priorities, with a high degree of initiative and good judgment
Ability to interface professionally at all levels of the organization

Senior Quality Systems Specialist Resume Examples & Samples

Bachelor’s degree and 5+ years’ of experience with configuration management, document control, process improvement and project management, database administration processes, or similar activities, in a regulated or highly structured environment (e.g., medical device, aerospace, automotive, military) or Masters Degree and 3+ years’ of experience with configuration management, document control, process improvement and project management, database administration processes, or similar activities, in a regulated or highly structured environment (e.g., medical device, aerospace, automotive, military)
Demonstrated track record of understanding and applying FDA’s Quality System Regulation and ISO 13485 requirements for quality management systems, including leading and supporting CAPA investigations or related activites in other regulated environments
Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
Proficient using the following software systems: Agile, SAP and Winshuttle
Experience using Agile PLM Import Tool and competent in Agile searches
Ability to work in a team environment as well as independently and with minimal supervision
Strong time management, organizational, and prioritization skills

Capa Quality Systems Specialist Resume Examples & Samples

Bachelors in the Science/Technical discipline (Quality/Regulatory)
2+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with Bachelors
Less than a year of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with a Masters
Familiarity with FDA requirements for a Corrective and Preventive Action Process
2+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with Masters
Previous experience in a regulated environment

Senior Capa Quality Systems Specialist Resume Examples & Samples

Bachelor’s Degree with 4+ years of experience in a quality role for medical devices and/or pharmaceuticals
Strong technical writing and documentation review skills
Experience with CAPA documentation systems (e.g. Trackwise)
Ability to process data and run statistical analysis to root cause, following flow diagrams, and producing process flow maps
Basic project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones)
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

Principal Quality Systems Specialist Resume Examples & Samples

7 + years experience managing Quality Systems within medical device or pharmaceutical manufacturing companies
A thorough working knowledge of the following: FDA 21CFR parts 820 and 11; ISO 13485, ISO 14971, Medical Device Directive; In Vitro Diagnostic Directive, Canadian Medical Device Regulation, Japanese PAL regulation and applicable Harmonization Standards that apply to medical devices and instrumentation
Quality certification preferred (e.g., CQE, CQA, CRE, CQM, etc)
Experience in medical device, pharmaceutical and/or a comparable regulated environment
Experience in external inspections by regulatory bodies (FDA, TuV)
Experience in a matrix organization
Experience reviewing technical documentation
Influence management skills; ability to work constructively across all functions of the organization as well as external customers
Well developed leadership skills
A working knowledge of process improvement skills including Lean Sigma
Ability to educate people in Quality Systems

Quality Systems Specialist Resume Examples & Samples

Maintains programs and processes to ensure compliance with current Good Manufacturing Practices (cGMPs)
Supports development and generation of quality system metrics
Works directly with internal clients to ensure follow-up of quality issues and completion of timely deliverables
May participate in the development of training programs regarding inspection readiness
May serve as a lead/coordinator of inspection readiness activities, corrective and preventive action (CAPA), and continuous process improvement from lessons learned
May assist in compliance audits of documentation as required
May interface with internal clients to address documentation and compliance issues
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, quality records, etc.) as needed
With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action
Implement and drive Quality system improvements
Must have an understanding and application of QA principles, concepts, industry practices, and standards
Applies knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis
Strong verbal, technical writing and interpersonal skills are required
Experience with implementation/improvement of quality systems. Interest and aptitude in writing is a plus
Experience in management of exception systems (e.g. Deviations, Laboratory Investigations, Corrective and Preventive Actions)
Experience in developing and generating Quality System metrics/trending
Experience in providing regulatory inspection support for regulatory inspections
Experience with GxP Electronic Systems (e.g. Trackwise, Oracle, Documentum)
Previous experience in a Quality, Compliance, or GxP Laboratory/Manufacturing operations capacity
Six Sigma certification or CQE is a plus

Quality Systems Specialist Resume Examples & Samples

Work with team to help organizations to develop, implement and maintain Quality Management Systems
Assist in establishing Quality Management policies, processes and procedures in line with an organization and their goals
Support development of training programs, including create training materials and conduct training sessions
Assist with the development of quality manuals, documents, procedures and training materials
Implement appropriate methods, fill in technical details, identify problems and implement solutions, developing new methods if necessary
Support the Quality Management Team
Develop SOPs and other documentation
Work with teams on reporting and data analysis needs and requirements
Assist with conducting of internal assessments at client sites
Develop materials to be used to present research results to clients
Participate in multiple, assigned research projects with supervision and within time and budget constraints
Build relationships with internal and external clients
Plan and carry out appropriate professional self-development activities
Recognized by the American Society for Quality as a Certified Quality Improvement Associate or Certified Process Analyst
Knowledge with CLSI QMS04-A1, ISO 9001:2015 or ISO 15189
Experience with internal assessments or audits
Background or experience in the molecular basis of cancer
Background or experience in the application of genomic or proteomic technologies

Quality Systems Specialist Resume Examples & Samples

Apply quality principles to projects, document approval, problem resolution, and other activities supported by the Quality organization
Track and communicate status of projects and performance metrics
Guides teams via communication of internal policies/procedures, external regulations, and industry best practices as they apply
Ensure the implementation of applicable compliance standards; may provide support during regulatory inspections and internal audits
As the site subject matter expert, implement and maintain the Deviation/CAPA system with support of corporate functions
Develop tools to track and trend of deviations and CAPAs and communicate program performance to key internal and external stakeholders
Provide training, and assign users roles for the electronic deviation and change control management systems
Provide training and assign users roles for the electronic deviation and change control management systems
Facilitate metric review meetings, communicate site performance and progress to targets, provide meeting minutes, and follow-up on action items
Present to senior management, both site and corporate
Work with other process owners to develop meaningful metrics for communication of system health to management
Bachelors Degree in an engineering or science discipline or commensurate level of industry experience
A minimum of 8 years of relevant experience
Experience with clinical or commercial pharmaceutical/biopharmaceutical products
Ability to communicate to drive action and inform of project status
Ability to lead meetings, train staff, and to provide and report metrics
Demonstrated knowledge of relevant regulatory guidance and industry best practices
Experienced with electronic quality systems, Trackwise preferred
Experienced with MS-Word, Excel, Project, PowerPoint, SharePoint, OneNote and Visio
Excellent technical writing, communication, and analytical skills
1603632

Quality Systems Specialist Resume Examples & Samples

Defines and maintains quality engineering processes, resources, infrastructure and program plans
Plans and develops proposals and cost estimates to support new business activities
Reviews, comments and approves life-cycle documents and program products
Plans and conducts audits of engineering processes and associated support functions
Assures compliance to established test plans and procedures and verifies test results
More than 1 year of experience in MRB (Materials Review Board) and/or corrective action
American Society for Quality (ASQ) Certification (CQA, CQE, CQT, etc.)
Experience in a Software Quality Environment
More than 1 year experience with Quality Management Systems (QMS)

Quality Systems Specialist Resume Examples & Samples

Proposal experience
Quality Assurance, MRB and Corrective Action
Experience utilizing a Quality Management System or AS9100 working with statistical methods and corrective action processes and tools
Computing Software experience desired
Hardware product acceptance experience desired

Quality Systems Specialist Resume Examples & Samples

Review of records and documents, for completeness and compliance with QSR and ISO requirements
Review of batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products
Generation of standard operating procedures to define and improve quality system functions
Support of the Material Review Board, for the assessment and disposition of non conforming materials
Support of the Agile electronic documentation process as needed
Lead and participate in interdepartmental initiatives for continuous improvement
Provide company-wide training on general quality principles and specific procedural requirements
Facilitate process improvement within other department, through the use of training, coaching, and team participation
Support of the corrective action program, with hands on ownership for investigation and resolution of issues
Participate in the internal auditor program
A minimum of 4 years experience with a bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment
Excellent verbal and written communication skills are a must; in group or one-on-one settings
Computer skills essential, e.g., word, excel, access, Microsoft project, electronic documentation systems, ERP systems
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics
Understanding of general mathematical principles and calculations, at college entry level
Ability to perform routine statistical applications
Understanding of SPC techniques
Experience in compiling data to support metrics analyzing current process
Understanding the Design of Experiments, root cause analysis, failure analysis, six sigma and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting
Experience in DNA diagnostics or other medical devices is preferred
Certified Quality Engineer, Certified Quality Auditor or similar certification a plus

Quality Systems Specialist Resume Examples & Samples

Establish & maintain Documentation and Training systems in full compliance. Act as a key user and system administrator for systems as and when required. Responsible for trend reports
Archive documents owned by QA, to support external and internal audits
Involve in developing/maintaining/standardizing training outlines and training matrices for the different departments
Coordinate within site and with relevant global Novartis group/s for implementation and maintaining of current knowledge of Corporate Quality Manual, Policies and any other legislative requirements on site

Quality Systems Specialist Resume Examples & Samples

At least 3 years experience in Quality Planning and Drawing Review
At least 3 years performing in the capacity of a Program Quality Specialist or Program Quality Engineer
Experience in creating Basis of Estimates

Quality Systems Specialist Resume Examples & Samples

Review records and documents, for completeness and compliance with QSR and ISO requirements
Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products
Generate standard operating procedures to define and improve quality system functions
Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports
Support the eDMS electronic documentation process as needed
Provide companywide training on general quality principles and specific procedural requirements
Support the corrective action program, with hands on ownership for investigation and resolution of issues
Bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience
A minimum of 4-6 years of relevant experience
Excellent verbal and written communication skills in group or one-on-one settings
Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems, ERP systems
Experience in DNA diagnostics or other medical devices
Certified Quality Engineer, Certified Quality Auditor or similar certification

Quality Systems Specialist Resume Examples & Samples

Oversight and administration of assigned Quality Systems
Lead activities to identify, develop, train and implement new Quality Systems globally and/or locally
Lead implementation and improvement projects for current systems
Communicate and work with global systems' IT, site SMEs and Quality Center Administrators/System Owners
Manage the site Notification to Management program
Track and report Regulatory commitments
Support Regulatory inspections
Lead quality systems related investigations
Manage and track the site's compliance with Zoetis Quality Standards (ZQS)
040-2
Bachelors with two years' experience or equivalent experience in biological or pharmaceutical sciences, engineering, computer or related discipline
A minimum of five years progressive experience in the quality systems, quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human pharmaceuticals or biologicals business
060-1
Bachelors with three - four years' experience, Masters with two years, or equivalent experience in biological or pharmaceutical sciences, engineering, computer or related discipline
060-2
Bachelors with five - eight years' experience, Masters with three years, or equivalent experience in biological or pharmaceutical sciences, engineering, computer or related discipline
Training small & large multi-disciplinary groups
Leading Manufacturing and Laboratory investigations
Using computer based Quality systems
Demonstrated ability to troubleshoot and reach targeted conclusions
Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments, sites and management levels
Proven ability to operate in an independent manner and to manage multiple projects at one time
Ability to lead multi-disciplinary investigations and projects
Knowledge of USDA, EU and FDA requirements of a biological and pharmaceutical manufacturing facility
Ability to make critical decisions related to system changes and testing required qualifying those changes
Strong Technical/User knowledge of Laboratory Information Management System, Enterprise Resource and Planning System (SAP), QAB and Event Tracking System (ETS)
Proficiency in building reports and queries from computer based systems

Quality Systems Specialist Resume Examples & Samples

Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes
Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required
Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc
Conducts internal audits to ensure compliance to regulatory and customer requirements
Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions
At a minimum a Diploma in a Quality, Science or Engineering discipline 3 or more years of related experience
Desirable a Degree in a Quality, Science or Engineering discipline with 5 or more years of related experience
Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met
Demonstrate excellent communication skills (verbal and written) with all levels within the organization, clients and regulatory auditors
Demonstrated success in managing multiple projects
Ability to develop and give presentations on technical and regulatory topics
Ability to work on own initiative and a high level of attention to detail
Ability to train/mentor associates
Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues
Ability to read, analyze, and interpret complex technical documents and manuals
Ability to define problems, collects data, establish facts, and draw valid conclusions

Senior Quality Systems Specialist Resume Examples & Samples

Responsible for the day to day administration of the Corporate CAPA and NCE system and assigns appropriate CAPA and NCE Owners and approvers per SOP requirements
Reviews and approves CAPA documentation to ensure completion of activities and compliance to good documentation practices
Acts as the corporate subject matter expert on CAPA and interface effectively with management personnel in Engineering, Manufacturing, Regulatory Affairs and other technical disciplines
Supports CAPA owners and other roles as applicable with questions related to the CAPA process and system
Disseminates CAPA relevant information to site, regions and corporate management
Coordinates CAPA Review Board Meetings and maintain meeting records per applicable SOPs
Responsible to maintain procedures and training material in compliance with internal and external requirements for the applicable areas of responsibility
Act as train the trainer on problem solving and root cause analysis activities and tools
Generates daily, weekly, and monthly Quality System trending reports; seeks to improve reporting processes to ensure unified approach and procedures. Presents reports and materials at divisional meetings and updates reports as appropriate with any key issues or customer concerns
Develops processes and procedures for data collection and trending in accordance to Hologic policies, procedures and in compliance with the applicable regulatory requirements
Manages the process to gather and communicate quality systems Key Performance Indicators across the organization
Ensures timely completion of projects assigned within budget; audit effectiveness of project to ensure business objectives are achieved
Acts as a “super user” for the applicable global quality systems software tools and its interfaces assisting user’s questions, troubleshooting, escalating issues to IS and working through the solution
Accountable to provide support for internal and external audits as required
Manages communication around project expectations with users; provide overall project status updates to stakeholders
Responsible to conduct investigations and drive corrective actions to address compliance issues related to the areas of responsibility
Demonstrated project management skills
Excellent interpretation of complex statistical data
Demonstrated written communication skills
Strong verbal communication and listening skills
Highly thorough and dependable
Strong working knowledge on Microsoft office suite
6 Sigma Black Belt Certification preferred
5 years’ experience working in a regulated environment under 21CFR Part 820 and ISO13485
5 years’ quality system experience

Quality Systems Specialist Resume Examples & Samples

Administer, improve, and maintain all aspects of the Berg Training and Education Program
Administer all Quality Programs such as deviations, change management, out-of-specifications, GMP investigations, and corrective and preventative actions
Collaborate with Engineering, Manufacturing, and Quality Control to fully support equipment qualification and analytical methodology validation
Represent Quality Assurance on project teams
Supervise the daily activities of the Quality Assurance Technicians to ensure efficient flow of materials and timely completion of production dependent Quality Assurance duties
General oversight of document systems for batch records and controlled documents
Lead or assist with continuous improvement exercises regarding Quality System functions
Lead or assist in auditing or investigation on activities, perform root-cause analyses, and develop corrective and preventative action plans
Develop and maintain appropriate document storage and retrieval systems
Provide support during regulatory inspections and audits
Provide periodic trend reports to senior management as required
Other related duties as required
An academic degree or equivalent education and experience; certification as a trainer or auditor is a plus
Five to eight years of working within the pharmaceutical industry with a full understanding of the cGMP regulations during development with emphasis on training, qualification/validation, and quality system requirements
Excellent communication, negotiation, and interpersonal skills
Attention to detail and analytical thinking
Ability to initiate and execute work independently; a self-starter
Computer skills: Microsoft Office, Microsoft Access, Adobe Acrobat
Good general administrative/office skills

Senior Quality Systems Specialist Resume Examples & Samples

Serve as the SME/primary contact/lead between Global Manufacturing sites and J&J Medical Canada for product hold process. Key responsibilities include the following but not limited to
B. Sc., Science, Engineering, or other related degree required
5+ years' experience working within a regulated environment. Experience required in a medical device or pharma Quality/Regulatory environment
Strong knowledge of pharma and/or medical device Quality Management Systems
Certified ISO: 9001 or ISO:13485 Lead Auditor preferred
Internal/External/Supplier Audits experience required
Recall execution, familiarity with Health Canada regulations governing medical device / pharmaceutical recalls
Experience with Process Excellence / Lean / TQM and Quality Systems auditing an asset

Principal Quality Systems Specialist Resume Examples & Samples

7+ years of experience with Bachelor’s Degree
5+ years of experience with Master’s Degree
Strong knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations (US and OUS)
Time and project management skills
MBA or MS Degree in Engineering, RAC or CQA Certification ASQ Certification
Experience with TrackWise, Visio
Effective oral communication skills
Experience with Class II or III medical devices
Experience in capital products and field services
Physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Principal Quality Systems Specialist Resume Examples & Samples

7+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance including 5+ years of direct FDA experience
Bachelor’s degree in Engineering, Computer Science, or related discipline
10 years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance with exposure to hardware/software development, manufacturing and distribution with at least 7 years of direct FDA finished medical device experience
Leadership skills associated with influence management, execution and people development,
7+ years of experience in Medical Device Quality Assurance, Compliance and/or Operations
5+ years of direct FDA experience
Expansive technical expertise facilitating front and back rooms for FDA and Notified Body Inspections
Semiconductor and/or electronic manufacturing experience is highly desired but not required. Strong understand of FDA regulations (21 CFR 820, 11), ISO 13485:2003/2016

Quality Systems Specialist Resume Examples & Samples

Design, develop and implement Document Control Systems
Responsible for reviewing and making recommendations to company procedures and forms to ensure compliance
Maintenance of all documentation regarding Quality System implementing Policies, SOP's, Work instructions, Job Aids, Validation documents, checklists, forms, etc. including distribution of controlled hard copies, posting of controlled electronic copies and
Must be detail oriented to detect errors
Good typing and computer skills, including MS Office Suite
Ability to manage multiple priorities in a fast-paced environment

Quality Systems Specialist Resume Examples & Samples

Must be proficient with MS Office suite of software and aptitude for learning and comfort with working in complicated system software such as CostPoint and TipQA
A minimum of 2 years professional experience
Strong interpersonal skills and ability to work well with others and in a team environment
Ability to interact with personnel throughout the plant
Strong organizational skills and eye for detail
Willing to implement and proactively use the principles of PES to support continual improvement

Quality Systems Specialist Resume Examples & Samples

The ideal candidate must have 10 years of experience with internal audits
Experience as a Certified Lead Auditor would most definitely be a plus
They should also have experience as a Lead auditor conducting training
5 or more years experience conducting hardware and system level audits to determine compliance using QMS (Quality Management Systems) standards, Regulatory and Customer Requirements are highly desired
Experience working with third-party service providers and/or independent auditors is required

Quality Systems Specialist Resume Examples & Samples

The ideal candidate should have formal training and practical experience in root cause analysis and corrective action; and familiarity with the Boeing Problem Solving Model
Data management skills; familiarity with Microsoft Excel, Access (or other database software)
Experience leading diverse teams, initiatives, or projects that demonstrated improvement to cost and quality and the ability to influence change
Value Stream Mapping certification is highly desired
Well-developed skills in Statistical techniques and approaches, including descriptive and inferential analysis, trending, predictive and causal analysis, statistical control and capability analysis
Experience improving processes in a transactional (office) environment: the ability to apply quality strategies across a wide range of functional areas, such as the supply chain, engineering, technical publications and fleet performance; to collaborate with or lead a team of SME’s chartered to bring about significant improvements in business performance, or quality outcomes

Quality Systems Specialist Resume Examples & Samples

Leads Quality reviews of proposals, contracts, regulatory, program and customer requirements to develop quality assurance strategies, plans and tests for hardware and software products, processes and services ensuring early quality involvement in program development
Develops and implements processes for determining, verifying and meeting requirements. Supporting modification activities on Tinker AFB and in the Receiving Dock/Warehouse
Performs Inspections and provide coordination with the customer in support of DD 250 Processing and nonconformance processing and management
Analyzes Earned Value Management data and develop Cost Variance Analysis Reports
Maintains processes, procedures and metrics to assure program, contract, customer and regulatory requirements are adhered to
Leads stakeholders in analysis of unfavorable process data, customer complaints and metric results formulating a mitigation plan utilizing the closed loop preventive / corrective action process
Analyzes data to provide material review dispositions for complex nonconforming conditions on materials, parts and equipment
Performs Corrective Action investigations on complex aircraft systems
Conducts quality source selection and process capability assessments of suppliers to verify their ability to meet program quality requirements and support business decisions
Develops Quality criteria for supplier source selection. Works closely with Supplier Management and Supplier Quality to ensure requirements are flowed adequately
Experience utilizing and following detailed work instructions, reading and interpreting blueprints, drawings, or specifications
More than 3 year of experience in MRB (Materials Review Board) and/or corrective action experience
Experience analyzing supplier proposals

Quality Systems Specialist Resume Examples & Samples

Participates in Quality reviews of proposals, contracts, regulatory, program and customer requirements to develop quality assurance strategies, plans and tests for hardware and software products, processes and services ensuring early quality involvement in program development
Supports the development of Quality budget and cost estimates
Assists in the development and implementation of processes for determining, verifying and meeting requirements
Assist in analyzing Earned Value Management data and in the development of Cost Variance Analysis Reports
Participate in the maintenance of processes, procedures and metrics to assure program, contract, customer and regulatory requirements are adhered to
Assist in the process of leading stakeholders in analysis of unfavorable process data, customer complaints and metric results formulating a mitigation plan utilizing the closed loop preventive / corrective action process
Assist in analyzing data to provide material review dispositions for complex nonconforming conditions on materials, parts and equipment
Participate in Corrective Action investigations on complex aircraft systems
Participate in source selection and process capability assessments of suppliers to verify their ability to meet program quality requirements and support business decisions
Assist in the development of Quality criteria for supplier source selection
Works closely with Supplier Management and Supplier Quality to ensure requirements are flowed adequately
More than 1 year of experience in Quality Assurance and corrective action
More than 1 year of experience conducting root cause analysis and developing/implementing corrective action plans
More than 1 year of experience in MRB (Materials Review Board) and/or corrective action experience

Quality Systems Specialist Resume Examples & Samples

Advanced/expert knowledge of quality systems such as ISO 9001, Aerospace Standard (AS9100) and CMMI
Experience leading quality audit and certification processes within global organizations focused on Engineering & Technology activities. Candidates who have successfully established or managed a Quality Management System in a previous organization will be preferred
Thorough knowledge of quality related metrics and processes for hardware and software products
Experience working with cross-functional teams spread across multiple products and locations across different cultures and time-zones, and working with external partners
Skilled in advising and mentoring staff members to meet quality goals in the context of technical or operational challenges
Ability to understand and communicate with technical experts over a wide range of technical topics
Strong project management skills to translate strategy into actions and follow through to achieving results
Ability to accomplish results through employees who may not be direct reports
Teamwork is important in this position; individual must have strong teambuilding skills, and demonstrated record of working with stakeholders in multiple international time zones
Must be flexible, with a high tolerance for organizational complexity and leverage it to address complex issues
Communication – strong written and verbal communication skills, ability to prepare comprehensive reports, proposals, Statements of Work, and ability to persuade others to follow the organizational goals and objectives. Candidate must be fluent in English, and have high level of expertise in using MS Office tools
Must be able to mentor team members and partners to accomplish project and departmental goals and objectives
Knowledge of aviation industry is preferred
12+ years of experience with at least 5 years as a Quality leader/specialist
Bachelor’s degree in Science, Technology, Mathematics, or Engineering is required and Master’s degree is preferred. Experience in leading a group of quality experts is a must
Candidates with experience in Aviation domain will be highly preferred
Experience working in a global organization is preferred

Quality Systems Specialist Resume Examples & Samples

Initiate programmes, analyse and provide advice to support departments
Conduct research or constantly check for updates or reviews of quality QPs and accordingly advise factories
Facilitate factory quality meetings or talks
Coach and or train Team managers and shop floor on new QPs or updated or reviewed QPs
Bachelor’s Degree in Food Science and Nutrition Technology and/or Chemistry
MS Office package (Word, Excel, PowerPoint, Projects and Outlook)
Working knowledge of Quality Management Systems
Sound Knowledge of FMCG environment
Strong driver for change and high levels of adaptability to change and
To pay attention to details
Ability to solve problems and determine root causes
Ability to handle pressure and meet strict deadlines
Strong level of Accountability
Incumbent must be assertive and show desired levels of aggression to see results
Excellent interpersonal and communication Skills
At least 2 years’ work experience in a similar role in a FMCG environment
Exposure and Knowledge of industrial equipment

Quality Systems Specialist Resume Examples & Samples

Supplier Quality processes
Universal Product Review (UPR) including Material Review Authorization (MRA), supplier delegated MRB processes and more than 1 year experience in Materials Review Board (MRB) processes
Product review process

Quality Systems Specialist Resume Examples & Samples

Provide support to ensure facility is maintained in a state of compliance to current good manufacturing practices (cGMP) as directed by 21 CFR 820
Provide support to the QA and QS Departments by performing functions which aid assurance of GMP compliance and assist in development and implementation of Quality Systems and Procedures for training
Facilitate the establishment of Quality System training requirements with QA management
Provide classroom or online Quality System training to newly hired temporary or permanent employees
Prepare and facilitate annual Quality System training in-house and for other sites as directed by Quality Management
Analyze, trend, and report on monthly, quarterly, and yearly employee training compliance data
In the Training system utilized for capturing and maintaining training requirements and records
4 year degree or 4 years experience in a medical device industry in the area of Quality Systems preferred
2 years experience in the medical device industry including knowledge of FDA and ISO and other related industry regulations required
Strong background developing , implementing , tracking and maintaining GMP and technical training programs preferred
Excellent presentation and platform skills and up-to-date knowledge of contemporary training modules with ability to provide stand-up classroom presentation, hands on demonstration, and course development assessment
Excellent written, oral communication, teamwork , and customer service skills
Able to provide classroom instruction without management oversight
Able to prioritize projects and adapt to shifting priorities
TRAVEL REQUIRED: 5-10% may be required for conducting off-site training support

Quality Systems Specialist Resume Examples & Samples

Familiarity with FDA and international Quality System requirements
Ability to manage multiple projects or priorities
Self-motivated and proactive team member
Ability to work well under pressure in a dynamic timeline-driven environment
Results-oriented and decisive

Quality Systems Specialist Resume Examples & Samples

Leads Quality reviews of complex proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development
Represents the Company on industry working groups to develop industry standards for quality
Advises senior leadership on development of business strategies that influence directives and policies
Advises multi-function groups on development of processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Consults in high level reviews of corrective actions at the enterprise and customer level to assure that trends or systemic issues are identified and advises on development and implementation of preventive or corrective actions
Conducts research, compiles and analyzes performance reports and process control statistics to continuously improve process capability
Develops new applications for statistical tools to maintain and improve process capability
Conducts business unit risk analysis to determine audit focus areas
Develops and manages business unit audits plans and schedules
Trains and advises senior management on preparation for third party audits
Performs benchmarking of enterprise best-practices
Works under consultative direction
Experience performing Root Cause Analysis (RCCA) using any of the following tools; 5-Why, Knot Charting, Ishikawa diagramming
More than 10 years of experience in Quality Management Systems (QMS)
Experience interpreting engineering drawings and specifications
Experience with testing and troubleshooting of electronics and Electrical systems
Experience with AS9102 First Article Inspection

Principal Quality Systems Specialist Resume Examples & Samples

7+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance
7+ years experience managing Quality Systems within medical device or pharmaceutical manufacturing companies
A thorough working knowledge of the following

Quality Systems Specialist Resume Examples & Samples

Review records and documents for completeness and compliance with QSR and ISO requirements
Create Certificate of Conformances for each lot released
Review the QC measurement data and upload the data and Certificate of Conformance into an on-line database for each lot
Create and apply approval labels for release products
Coordinate with the Shipping Department the shipping of release parts to the production facilities
Perform material movement and release transactions in the company’s ERP system
Create and Maintain inventory of retains samples that are stored offsite
Assist with corrective action activities in the resolution of issues
High school diploma with at least 2 years of work experience in a manufacturing environment
Work related experience in a medical device company or regulated environment
Proficient with Word, Excel, Access, and electronic documentation systems/ERP systems
Basic experience in compiling data to support metrics analyzing current process
Ability to interface effectively with a cross-functional team environment
Strong aptitude for learning new materials quickly
Strong attention to details skills
Associate’s degree a plus but not required

Senior Quality Systems Specialist Resume Examples & Samples

Oversees and administers SOP, document and records management system, as well as the deviation, change control, complaint handling, training and CAPA systems at the site. This entails ensuring that the processes, their respective procedures and their use meet current regulatory expectations and industry best practice
As Super User for Master Control, the Quality Systems Specialist works closely with System Administrators, Users and IT to ensure the system is used as intended. The Quality Systems Specialist is the business subject matter expert in the processes facilitated by the MasterControl document management system
Participates in MasterControl projects in the continued improvement of the system and roll out across other sites. Typical activities may include, leading the development of user requirements, training of users as needed, testing of new functionality, development of SOPs and leading the Master Control SME Forum on a monthly basis
Uses appropriate tools to compile, track, trend, analyze and report key performance indicators and metrics in order to identify areas of non-compliance, best practice and improvement opportunities
Prepares information related to the state of the QMS to be used in routine monthly reporting and Quality Council meetings
Proactively, based on data analysis, recommends to management areas of improvement within the various operations
Maintains the supplier quality management program, ensuring that vendors and suppliers have been properly qualified/re-qualified prior to their use in GMP activities
Conducts vendor/supplier audits. These could be desk audits or physical audits based on procedures and documented risk assessment
Develops the plan, maintains the program and ensures delivery of the GXP training for the site. Monitors applicable metrics in order to evaluate whether the program is effective
Maintains inspection ready procedures, data and records pertaining to the QMS and participates in internal and external audits and regulatory inspections
Participates in self-development activities to stay current with regulatory expectations and industry best practices in quality management systems
Complete the Albany Quality Assurance Core Competency in the MasterControl Document management system
BS preferably in Chemistry or a related field
At least five years of industrial GMP experience in an FDA-regulated pharmaceutical environment
Basic quality tools (i.e. pareto charts, histograms, cause-and-effect)
Experience in QMS platforms a plus (i.e. Documentum, TrackWise, MasterControl)

Quality Systems Specialist Resume Examples & Samples

Support the Material Review Board, for the assessment and disposition of non-conforming materials and participate in the verification of actions taken throughout the Non-conformance process for the closure of Non-conformance and Deviation Reports
Support interdepartmental initiatives for continuous improvement
Partner with departments to promote improvements through the use of training and coaching
Support the corrective action program in the investigation and resolution of issues
Support the eDMS electronic documentation process, as needed
Participate in the internal auditor program, as needed
High school diploma or education equivalency and experience
1-2 years of practical experience in a regulated manufacturing environment
Computer skills, e.g., Word, Excel, Access and electronic documentation systems, ERP systems
Understanding of general mathematical principles and calculations
Associate’s degree a plus
Work related experience in a regulated environment
Previous experience reviewing batch records a plus

Quality Systems Specialist Resume Examples & Samples

Bachelor’s degree from an accredited university
Minimum of 5 years’ experience of manufacturing experience
Minimum of 2 years’ experience with quality documents such as Gage R&R, PPAP’s, FMEA’s, Control Charts, Control Plans, SPC related reports and/and calculations
Miinimum of 2 years’ experience with ISO/AS9100 quality systems
Minimum of 1 year experience with Internal Quality Systems Auditing
Customer interface experience
Previous experience in TS 16949 Implementation and certification
NADCAP is a plus
ASQ, CQA, CQE and/or CQM desirable

Quality Systems Specialist Resume Examples & Samples

Supplier Qualification System Owner: conducts onsite/paper audits of suppliers and ensures adherence to the Supplier Qualification Program
Administers assigned Quality Process. Duties include issuance of process tracking numbers and completion associated tasks according to established Standard Operating Procedures (SOP)
Generates and maintains Quality data and associated metrics according to established SOPs
Reports Quality metrics according to established SOPs or by Management request
Leads team on improving assigned quality processes
Becomes the Subject Matter Expert (SME) for the assigned Quality processes
Authors and leads development / modification / improvement efforts associated with Quality SOPs
Provides and prepares documentation and materials for/in various reporting forums for internal and external customers
Leads and/or participates in Quality System reporting forums assessing compliance with cGMP and other applicable regulations
Participate/Lead in quality and process improvement initiatives, and project teams
Conducts internal and client audits
3 - 5 years GXP experience - or equivalent training and/or experience
HS Diploma or Equivalent, BA/BS in a Science related major preferred

Senior Quality Systems Specialist Resume Examples & Samples

Act as an EtQ administrative support SME for NC / CAPA
Act as a Change Management SME in support of CR's to be processed and other D&DC administrative functions
Act as a Training LMS SME to ensure the requirements of the Training Management process are being adhered to
Scheduling, coordinating, execution of Monthly Management Review
Providing input into Quarterly and Bi-annual Management Review
Ensuring procedural alignment to FDA / ISO regulations and JNJ standards
Overall maintenance of the Quality Systems Scorecards
External and JNJ standards - manage the process for ensuring gap assessment completion and assignment of owners for changes to the Quality System
Recall coordination, act as the SME to execute the tactical elements of a recall
Act as a site Records co-coordinator in liaison with the Franchise Records Manager, to ensure the site is in compliance with the requirements of the WWRIM program

Quality Systems Specialist Resume Examples & Samples

Persuasive, willing to take the initiative, and adaptable with first class communication skills
Ability to build good relationships with, Procurement, Regulatory, Sales, R&D, Technical Service, ICD and Applications
Bachelor's degree, or equivalent, in a science-based area of study (Biology, Microbiology, Food Science, Chemistry)
Strong food industry experience managing people coupled with strong supplier quality related experience in the food industry
Working with, and knowledge of, regulatory requirements in the food industry
Working knowledge of SAP or other ERP systems
Working knowledge of tools such as TraceGains, SharePint, etc
Strong knowledge of Quality methodology
Cross functional communication skills
Good knowledge of quality certifications like HACCP, BRC, ISO, etc
Experience reading and understanding supplier Technical Data Sheets
Ability to handle multiple tasks simultaneously while maintaining attention to detail

Quality Systems Specialist Resume Examples & Samples

Reviews and approves process, assay, and other validation protocols and reports thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls
Participates in the audit or inspection of vendors or partner organizations relative to their creation of computer system products, use of computerized systems, or calibration, preventive maintenance and equipment qualification service, as assigned by management
Reviews proposed changes to validated systems and assists with the identifcation of validation requirements necessary to maintain the system’s validation status after execution of the change
Represents QA on cross-functional project teams such as tech transfer, process validation, and process improvements
Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken
Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken
Writes new documents and revises existing documents, independently
Performs QA review/approval of controlled documents
Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently
Participates in internal audits as needed
Develops and provides training on department-specific procedures and systems
Identifies, proposes, and implements Quality Process and system improvements
Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction

Quality Systems Specialist Resume Examples & Samples

Participating in the execution, maintenance and improvement of the Quality Management System
Assisting with preparation of quality system metrics
Assisting with other projects related to the Quality System
0-2 years of related work experience
Ability to understand engineering specifications across a number of products and materials
Quality assurance and reliability experience supporting product development and/or manufacturing is desired
Exposure to medical devices and regulation (FDA, ISO 13485, etc) is desired

Quality Systems Specialist, NCR & Capa Resume Examples & Samples

Support the development and implementation of effective policies, requirements and strategies for Quality Management System sub systems including, but not limited to NCR (Non-Conformance Reporting), and CAPA (Corrective and Preventive Actions)
Monitor and ensure Due Date Adherence for NCR and CAPA Quality Subsystems
Ensure that Quality subsystems are optimized to provide the most effective methods of compliance with internal, European, Franchise and Regulatory standard requirements
Liaise with relevant World Wide Quality Systems and Compliance groups to ensure local representation is maintained across NCR and CAPA Quality system activities
Involvement in / awareness of developments within the NCR and CAPA Quality Subsystems with a view to ensuring alignment of local processes and procedures
Provide regulatory interpretation, training and assessment within the organization to ensure NCR and CAPA Quality subsystems are aligned with current requirements, standards and industry trends
Administer relevant Quality subsystem applications and processes in compliance with corresponding Franchise requirements
Provide Quality subsystem process performance measurements to Quality and Operations Management as required
Work effectively with other Quality and Operations associates to ensure consistent and compliant Quality subsystems
Effective alignment and execution of objectives supporting appropriate WWQS & QC outcomes
Provide support during Notified Body, Competent Authority, Franchise, Customer and Internal Audits
Support and lead NCR and CAPA Quality subsystem improvements, which result from audits and any other Quality subsystem indicators
Perform other work-related duties as assigned by Quality Systems and compliance Lead
Comply with all environmental, safety and occupational health policies. (i.e., ISO14001 & OSHAS18001)
A minimum of a Bachelor’s Degree is required, Life Science, Physical Science, Engineering or equivalent is preferred
A minimum of 2-4 years of experience in related systems is required
Experience with Non-Conformances or Corrective and Preventive Action’s is required
Knowledge of Quality Systems Standards (BS EN ISO13485: 2003; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC) is preferred
Knowledge in database administration and data manipulation for analysis and reporting purposes is strongly preferred
Data interpretation and analysis / graphing is preferred
Ability to draw conclusions through data analysis to influence actions that improve quality and reduce risk is preferred
Good verbal and written communication skills with a good team working ethos
Ability to manage multiple items concurrently is required
Strong organization skills to address hundreds of NC / CAPA items that may be active at any time is required

Quality Systems Specialist Resume Examples & Samples

You stay informed of current and new regulatory requirements through a combination of internal and external training and participation in professional associations as appropriate. You interprets and communicates changes to affected functional areas
You will develop effective partnerships with internal staff and external organizations to facilitate the identification and resolution of quality matters and other opportunities for quality process improvement
You represent Quality Systems in multidisciplinary teams internal and external
You author, review and approve documents to ensure compliance with applicable internal and external requirements (e.g., change management, deviations, specifications, protocols, plans and reports, investigations, and SOPs)
You support management in the preparation for, conduct of, and follow-up activities associated with site visits and assessments of quality management system participates in and may lead the development, implementation, maintenance and continuous improvement of the site Quality Management System
You track, trend and evaluate quality data and generates detailed reports for management
You will perform and/or supervise the conduct of internal audits and assessments. You will either provide oversight and guidance on the identification and resolution of any findings
You will develop and conduct training for the Quality team and other employees

Senior Quality Systems Specialist Resume Examples & Samples

Responsible for active contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly
Bachelor’s or Master’s degree, preferably in science
At least 7 years of relevant experience in the pharmaceutical industry and cGMP
Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations
Extended knowledge of Quality Risk Management and tools, preferably Lean Six Sigma Green/Black belt trained
Experience with document/ quality management systems such as Sparta Systems (trackwise® and SAP is a strong plus)
Computer literacy knowledge
Structured working skills and continuous learning attitude
Effective planning skills and strong focus on clients and end-users
Ability to work independently and in a team
Ability to convert Quality Mindset into practice and to bring others on that same page

Quality Systems Specialist Resume Examples & Samples

Lead quality development and operation for all facets of a Boeing owned, state of the art Line Maintenance organization
Lead quality development and deployment of a worldwide Emergent Maintenance Team organization
Participating in the approval, oversight and performance management of contracted MROs (Maintenance, Repair & Overhaul)
Traveling worldwide to engage with Boeing employees, airport authorities, regulatory agencies, customer airlines, and contracted MRO suppliers
Act as the focal and mentor for a team of Quality Systems Specialists
Ensuring adherence to regulatory requirements
Oversight of maintenance activities from a Regulatory, Quality and Safety perspective
Supporting the Quality and Safety Organisation by engaging in multi-function, multi-site groups that develop company directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Leading stakeholders in analysis of process data, metrics, models and flows to identify root cause of complex problems and development and implementation of preventative or corrective actions
Conducting research, compiling and analysing performance reports and process control statistics to continuously improve process capability
Conducting quality source selection via approved processes and process capability assessments of suppliers' ability to meet program quality requirements and support business decisions
Developing Quality criteria for supplier source in conjunction with the larger Quality Organisation regarding the selection and a coordinated response for review and approval by senior management
Developing scope, scheduling, planning and leading hardware, software and system level audits to determine compliance with quality and safety management system standards, configuration assurance, related business, regulatory and customer requirements, and reports results to management
Training senior management on preparation for third party audits
Analysing data to provide material review dispositions for complex nonconforming materials, parts and equipment
Assisting in the development of new standard repairs for nonconforming materials, parts and equipment
Working under minimal direction
Conducting regular independent audits in order to proactively identify non-compliances and areas for improvement
Providing comprehensive assessment of all activities that ensure continued airworthiness of customer aircraft
Reviewing company systems, policies and procedures and making recommendations to management team
Reviewing and presenting findings and concerns with the appropriate personnel or representatives of suppliers or service providers
Investigating non-compliances to the required level and ensure appropriate corrective and preventative actions are taken
Ensuring adequate corrective and/or preventative actions are implemented, planned or accomplished for all audit findings
Reviewing and investigating accidents and incidents
Monitoring and ensuring timely closure of occurrence reports and reviewing trends
Communicating audit or occurrence report trends to management team
Evaluating closing activities associated with Air Safety, Mandatory Occurrence Reports and internal or external investigations
Liaising with regulatory authorities to resolve regulatory, quality and safety matters
Producing internal reports as required
Mentoring a team of Quality Specialists to ensure continuous development and maintenance of standards
Applicant must have an exceptionally strong working knowledge and understanding of commercial airline maintenance and engineering operations experience ideally gained from a Part-145 Aircraft Line Maintenance Organisation
A Part-66 Aircraft Maintenance Licence an advantage, but not a requirement
Applicant must be very knowledgeable of industry and regulatory agency requirements as applicable to the operation and support of transport category aircraft
Previous experience of working with Aircraft Line Maintenance MROs in relation to quality, safety, auditing, training, supplier oversight and staff approvals is a must have
A flexible and proactive attitude with a willingness to take on and complete tasks, whatever they may be
A willingness to work occasional shifts and/or additional hours to support operations
Proficient in the use of IT and associated software
Candidate must demonstrate a well-developed ability to communicate verbally and in written form
Extensive aviation engineering quality and safety experience
Experience of managing engineering authorisations
Quality auditor trained and experienced a requirement
Safety investigation experience and training a requirement
IT literate and knowledge of electronic aviation engineering and/or quality and safety management systems an advantage
Knowledge of and appreciation for just culture and SMS participation
Ability to contribute to development of management systems and processes
Exemplary attendance required
Must be willing to apply for and able to successfully receive a Dublin Airport or other Airport airside access pass
Experience using Q-Pulse would be a distinct advantage

Quality Systems Specialist Contract Position Until Dec Resume Examples & Samples

Processes job descriptions for approval and periodic review in applicable repository (e.g. TruVault, Summit, My Learning Plan)
Creates and maintains training courses, users, user groups and associated curricula
Assists functional areas in determining training needs for employees/contractors and in the identification of training audience
Develops/prepares and deploys training materials and programs to meet BQ organizational needs
Develops and maintains training plans/matrices with designated management from GxP areas
Performs data entry on training activities, issues reports, and department communications
Performs required reporting on training metrics/trends
Acts as liaison for segment and function specific training
Participates as a training subject matter expert on projects, councils or organizational groups, as required
Maintains SOP Management process (e.g. process and post SOP’s, Forms, Guidelines in document management system truVault or Docspace)
Supports document lifecycle for organization by drafting new or revised SOPs and supporting documents, initiating periodic review or retirement
Provides audit readiness and ongoing audit support including any corrective actions related to training and document observations
Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions
Collaborates with internal partners to ensure the consistency and efficiency of BQ training curricula and training systems
Communicates changes to or the introduction of new controlled documents along with any required downstream document management and training activities
Coaches/trains users of the document and training quality system processes
Identifies areas for process improvement and contributes to their implementation
Supports the implementation of various new/updated processes and tools (e. Summit deployment)
Maintains current with training requirements related to any specialized role in the electronic systems used in training and document management (e.g. TruVault, Summit, ComplianceWire)
BSc in Pharmacy, Chemistry, Microbiology, Biotechnology or Biochemistry or equivalent education or experience
Pharmaceutical Quality Systems experience (minimum 3+ years)
Experience in a pharmaceutical importing/distributing environment, with experience in a manufacturing environment preferred
Knowledge of current GxPs

Quality Systems Specialist Resume Examples & Samples

Review and improve existing process controls for quality metrics / Quality Systems
Provide support for Audit and Training Program related issues, including but not limited to the generation and processing of AFs, DCNs and CAPAs
Assist in creation of Quality Standards and visual aids for use in Training program
Perform internal audits, when required as lead or associate auditor. Compile required audit paperwork resulting from internal audits and associated findings
Update and maintain QSP’s and Work Instructions related to job function, as required to ensure compliance with ISO, QSR, MDD and other regulatory requirements for Medical Device Manufacturing
Facilitate resolution to quality system related issues using statistical techniques and/or other problem solving tools
Participate in External Audits as required
Assist QA Engineers, Complaint Handlers and QA Manager in the collection, analysis and reporting of data
AS/AA in an engineering discipline or equivalent training/experience
One year experience in electronics Manufacturing environment or equivalent
Prior manufacturing engineering and quality assurance functions helpful
IPC 610 Specialist training required
Supervisory experience is preferred, but not required
Knowledge of and ability to develop statistical methods to ensure that specified levels of safety, reliability and process capability are achieved, maintained, or improved
Knowledge of systems design, specification and analysis
Knowledge of IPC manufacturing standards
Electronic manufacturing background, preferably in a Medical Device Manufacturing environment
The ability to provide timely and accurate reports of data collection and analysis

Quality Systems Specialist Resume Examples & Samples

Developing and operating all facets of a Boeing owned, state of the art Line Maintenance organization
Developing and deploying a worldwide Emergent Maintenance Team organization
Ensure adherence to regulatory requirements
Support the Quality and Safety Organisation by engaging in multi-function, multi-site groups that develop company directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Leads stakeholders in analysis of process data, metrics, models and flows to identify root cause of complex problems and development and implementation of preventative or corrective actions
Conducts research, compiles and analyses performance reports and process control statistics to continuously improve process capability
Conducts quality source selection via approved processes and process capability assessments of suppliers' ability to meet program quality requirements and support business decisions
Develops Quality criteria for supplier source in conjunction with the larger Quality Organisation regarding the selection and a coordinated response for review and approval by senior management
Develops scope, schedule, plans and leads hardware, software and system level audits to determine compliance with quality and safety management system standards, configuration assurance, related business, regulatory and customer requirements, and reports results to management
Trains senior management on preparation for third party audits
Analyses data to provide material review dispositions for complex nonconforming materials, parts and equipment
Assists in the development of new standard repairs for nonconforming materials, parts and equipment
Works under minimal direction
Conduct regular independent audits in order to proactively identify non-compliances and areas for improvement
Provide comprehensive assessment of all activities that ensure continued airworthiness of customer aircraft
Review company systems, policies and procedures and make recommendations to management team
Review and present findings and concerns with the appropriate personnel or representatives of suppliers or service providers
Investigate non-compliances to the required level and ensure appropriate corrective and preventative actions are taken
Ensure adequate corrective and/or preventative actions are implemented, planned or accomplished for all audit findings
Review and investigate accident and incident reports
Monitor and close occurrence reports and review trends
Communicate audit or occurrence report trends to management team
Evaluate closing activities associated with Air Safety, Mandatory Occurrence Reports and internal or external investigations
Liaise with regulatory authorities to resolve regulatory, quality and safety matters
Produce internal reports as required
Applicant must have a strong working knowledge and understanding of commercial airline maintenance and engineering operations experience ideally gained from a Part-145 Aircraft Line Maintenance Organisation
Applicant must be knowledgeable of industry and regulatory agency requirements as applicable to the operation and support of transport category aircraft
Previous experience of working with Aircraft Line Maintenance MROs in relation to quality, safety, auditing, training, supplier oversight and staff approvals
Quality auditor trained and experienced an advantage
Safety investigation experience and/or training an advantage
This requisition is for an international, locally hired position. IT IS NOT FOR AN EXPAT ASSIGNMENT. Benefits and pay are determined in line with local country labor market practices. Please list all of the Countries in which you are a citizen and/or have work authorization for on the top of your resume.**

Quality Systems Specialist Resume Examples & Samples

Proficient in MS applications (Excel, Word, Outlook)
Excellent communication and attention to detail
Creative, analytical problem solving skills
ISO 13485 Internal Auditor Certification preferred
Experience with Master Control as a Document Management tool
Familiarity with Quality Systems Regulations and ISO13485

Senior Quality Systems Specialist Resume Examples & Samples

Lead the establishment & maintenance of Documentation and Training systems that support all business processes on site in full compliance with predicate rules and Novartis internal requirements
Act as a key user and system administrator for systems
Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables
File and archive documents owned by QA, and provide timely documentation & training support during the preparation for and execution of external audits (e.g. regulatory, corporate audits). Support internal audits by providing requested documents and support in a timely manner
Lead the establishment of standardized methods of training across the site using a diverse range of training materials
Develop/maintain with Subject Matter Experts (SME) and/or subject matter trainer, the training outlines and training matrices for the different departments in alignment with the site training strategy
Monitor system use for Documentation and Training; ensure timely preparation of trend reports for customer use and management reporting
Provide operational oversight and guidance to the Quality Systems team on related areas
Ensure consistent application of practices across the team
Lead system improvement programs with respect to achieving compliance, reducing waste and improving efficiencies, and CAPAs related to applicable systems
Maintain current knowledge of local and applicable international regulatory and legislative requirements and trends with respect to documentation & training management

Senior Quality Systems Specialist Resume Examples & Samples

A seasoned, experienced professional with full understanding of quality systems; resolves a wide range of issues in creative ways
Performs high level evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
Facilitates internal training on quality assurance requirements, processes, and procedures
May perform audits and risk assessments
Networks with senior internal and external personnel in own area of expertise
Normally receives little instruction on day-to-day work and general instructions on new assignments
Acts as a subject matter expert
Mentors other staff as applicable
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions
Minimum 5 – 8 years of related experience in Pharmaceutical/Medical Device Industry; with Master’s Degree 3 years required
Highly autonomous. Minimal supervision required
Self-starter with the ability to work well both independently and as part of a small team
Can prioritize tasks accordingly
Very detail-oriented, well organized, and driven to meet deadlines and program goals
Good computer skills with knowledge of Microsoft Office including Access, Lotus Notes, SAP, and Microsoft Outlook
Ability to work in a high stress environment given the nature and process
Ability to generate moderately complex spreadsheets with graphs for trending data and presentations
Knowledge and application of metrics and charts for quality system processes
Excellent project prioritization, planning, and management

Quality Systems Specialist Resume Examples & Samples

Experience in Learning and Development or Training environment required. Dynamic group presentation skills
Strong background in instructional design, development and delivery strongly preferred
Knowledge/experience in the implementation of robust training evaluation models preferred
Knowledge of instructional technologies a plus (enterprise LMS, e-learning course development)
Experience working in a regulated industry and/or in the delivery of GxP or Quality Systems training a plus
Working knowledge of the requirements of 21 CFR 820/211 and ISO 13485:2003 a plus
Minimum 2 – 5 years of related experience in Pharmaceutical/Medical Device Industry; with an advanced degree no prior years of experience may be considered

Senior Quality Systems Specialist Resume Examples & Samples

Provides support to the MMD Quality Standard/Compendia! customers. Participates in activities and provides appropriate support to Merck Network Sites as well as business partners {P3) in accordance to the approved supply agreements/contracts
Demonstrates continuous improvement though the ability to optimize functional performance and teamwork through the relentless pursuit and application of standards, best practices, appropriate tools, to positively impact individual and organizational performance, quality, and outcomes for delivery of value and competitive success
Ensures the review, approval and issuance of Quality Standards are performed in a timely manner and in compliance with departmental practices and GMP regulations. Performs the required Quality approvals of draft Quality Standard documents to progress to QS issuance
Provides guidance to other staff members
BS with minimum of 4 years experience or MS with 2 years post degree experience
Requires high level of technical knowledge and aptitude
Requires appropriate laboratory experience,knowledge of laboratory operations and analytical instrumentation
Requires ability to work independently and on teams,managing multiple projects/tasks simultaneously with competing priorities;managing meetings effectively, providing customer support, managing time and personal effort
Requires ability to think originally and imaginatively in developing creative ideas
Possess the skills to persuade and motivate others
Requires superior written and oral communications skills, advanced problem solving and proficient decision making skills

Quality Systems Specialist Resume Examples & Samples

Knowledge of regulatory requirements including 21 CFRs, ISO 13485 and other Quality System Regulations
Demonstrated experience with MS Word, Excel, Visio and Project
Demonstrated experience in administration of electronic systems such as PLM, ERP, and MDM systems
Prefer demonstrated experience with Windchill PLM and Oracle ERP
Demonstrated experience with processing change requests / notices through an electronic PLM system, performing change control review / approval and implementation of best practices for change management
Demonstrated experience with processing documentation, ECNs, procedures and specifications through an electronic PLM system, performing document review/approval and implementation of best practices for document control
Demonstrated experience with Quality Systems processes such as External Standards, Periodic Review and record retention
Demonstrated experience in item creation and maintenance activities in an electronic ERP and MDM system
Must have the ability to analyze, interpret and report on data across multiple systems ensuring data accuracy
Demonstrated ability to independently troubleshoot issues with electronic systems
Must have the ability to act independently and influence / make decisions in the best interest of patient safety and efficacy
Demonstrated ability to problem-solve and manage multiple tasks while assisting internal customers
Demonstrated experience in training users on systems and processes within an electronic environment
Demonstrated verbal and written communication skills
Must be a positive, energetic team player, and an advocate for product excellence and quality
Candidate should be results oriented, a multi-tasker, a quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
Experience working in cross-functional or cross-divisional environments is preferred. Minimum of 3-5 years’ experience in the medical device industry

Quality Systems Specialist m/f Resume Examples & Samples

Minimum 2-3 years proven QMS, RA and/or QA experience with medical electrical devices in an FDA-regulated industry; or equivalent combination of education and experience
Knowledge of US and EU medical device regulatory requirements
English (mandatory), German preferably

Quality Systems Specialist Resume Examples & Samples

Responsible for the administration and maintenance of the document control function, managed through the Agile PLM system, including reviewing change orders for correctness, rejecting change orders back to originator for correction, advancing change orders through the various stages of the workflow, assigning approvers at CCB and acknowledgers at pre-release, implementing the change order, and changing the lifecycle status
Maintains the Corrective and Preventive Action function, including the entry, promotion, closure of CAPAs and corrections in TrackWise and/or Oracle, presides over weekly CAPA and CRB meetings, and facilitating TrackWise access to new CAPA owners
Administers the Control of Nonconforming product process, including hosting of MRB meetings, documenting disposition and CAPA decisions, facilitating the execution of disposition, preparing rework instructions, performing re-inspections
Completes necessary actions to maintain the Calibration function, including: monitoring of gauges due for calibration, coordinating with the calibration suppliers to ensure timely completion of calibration, maintaining hard copy calibration records as well as updating calibration details in Oracle, and ensuring that measuring equipment is properly calibrated, identified, and labeled prior to use,
Responsible for the development and maintenance of the Internal audit schedule, confirm conformity of the Internal audit reports, and maintain records of completed Internal audits
Supports the OLM administrator by providing backup support as needed
Establish and maintain Quality Management System procedures as needed
Generates routine and non-routine metrics for any/all Quality System functions metrics and provide metrics and/or status updates to management, as required
Provides administrative oversight of Time Reporting program (Toggl), including the addition/removal of employees in the system, maintenance of Projects and Task lists, and ensuring the accuracy of time reporting to facilitate the use of date to calculate Cost of Poor Quality and other metrics
Experience required for one or more of the following QMS functions: Document Control, CAPA, Control of Nonconforming Product, Calibration, Internal Audits, and Training
Knowledge of FDA Quality System Requirements and ISO 13485 Quality Standards preferred
Experience working in Oracle, Agile and TrackWise systems preferred
Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures
Must be able to give and welcome constructive feedback; contribute to building a positive team spirit

Quality Systems Specialist Resume Examples & Samples

Bachelor degree in Industrial or Manufacturing Engineer or related
2+ years of experience in Quality Management area at an automotive industry
Knowledge of ISO standards. Certification is preferred
Experience at executing quality audits
Knowledge in problem solving techniques
MS Office knowledge

Senior Quality Systems Specialist Resume Examples & Samples

Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management
Administration and oversight of site quality systems including but not limited to
Deviations
Change Control
Audits
Corrective/preventative action documents
Standard operating procedures
Identify gaps in systems and develop feasible plans for correction
Requires BSc/BEng in scientific discipline or related field with 5+ years of relevant work experience in pharmaceutical or related industry
Good working knowledge of electronic Quality Management Systems and associated metric generation preferred
Proficient at report generation using Excel and other MS Office applications

Quality Systems Specialist Resume Examples & Samples

Coordinating of Corrective Action Board (CAB) meetings, including scheduling, issuing minutes and records
Review and remediation of current quality system documentation to maintain compliance with FDA, international regulatory requirements, and corporate policies/procedures
If qualified, may conduct routine and directed internal audits to assure compliance with FDA regulations, international standards and requirements, local SOP’s and corporate policies/procedures
1 year of experience

Senior Quality Systems Specialist Resume Examples & Samples

5+ years of experience in technical writing and document/records management in a regulated industry
Experience with application of ISO 13485 and 21CFR 820 requirements
Experience providing leadership and work direction to global teams
Excellent relationship and influence skills to drive change with a high level of diplomacy
Organizational change management certification
Working knowledge of information and content management practices
Demonstrated results driving change in large, complex business environments and global organizations
Strategic and systems thinking aptitudes
Consistent delivery of objectives
Experience partnering with IT and implementing IT solutions
Experience with content management and learning management technologies
Excellent relationship building, influencing, negotiation, communication, facilitation and presentation skills
Excellent planning, program management, and consulting skills
Experience developing medical device quality systems across multiple geographies
While performing the duties of this job, the employee is regularly required to be independently mobile
The employee is also required to interact with a computer for extended periods of time, and communicate with peers and co-workers
Ability to travel both domestically and internationally up to 15%

Quality Systems Specialist Resume Examples & Samples

Bachelor’s Degree with 2+ years of work experience in a regulated industry or Masters’ Degree and 1+ year of work experience in a regulated industry
Experience in medical device/pharmaceutical/biotech in quality
Familiar with ERP Systems (such as Agile and/or SAP, or equivalent systems)
Working knowledge of quality assurance systems, methods and procedures
Working knowledge of Microsoft Office applications (Word, PowerPoint, and Excel)
Familiar with Medical Device Regulations or equivalent regulatory standards
Knowledge of current Good Manufacturing Practices (GMPs) and/orFDA code 820 requirements for patient labeling
Able to work under pressure, in a fast paced environment and set priorities to meet challenging project deadlines
Self-starter with eagerness to learn and expand responsibilities
Basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations
Configuration Management Certification
Strong organization, customer service and interpersonal skills

Senior Quality Systems Specialist Resume Examples & Samples

University Degree or equivalent experience and 4-7 years prior relevant experience
Occasional: Activity exists less than 1/3 of the time
Frequent: Activity exists between 1/3 and 2/3 of the time

Quality Systems Specialist Resume Examples & Samples

Assist in overall operations program improvements by providing feedback and revising processes
To effectively audit assigned sites verifying all expectations and requirements are met or exceeded
Provides suggestions for continuous improvements in the areas of process improvement and program consistency
Facilitates communication and information flow for effective issue resolution as it relates to program adherence/audits
Strong practical and application of skill and knowledge of data center infrastructure systems
Internal team building
Technical understanding and communication to peers/management and client POCs
Advanced knowledge of Microsoft Office to include sharepoint, word, project, and excel
Understanding and implementation of risk mitigation processes
Emergency response and escalation planning
Ability to do on the job training in the areas of procedure creation, review and management as appropriate
5 years or more mission critical environments experience
We seek out and reward people for being straightforward, open, passionate, effective and challenging the status quo. We want our employees to reflect the diversity of the communities in which we operate. We welcome people as they are, creating an inclusive culture where all forms of diversity are seen as a real value for the company. We’re looking for people with a passion for success — on the job and beyond. See what our people have to say about working for Schneider Electric: https://youtu.be/6D2Av1uUrzY

Configuration Assurance & Quality Systems Specialist Resume Examples & Samples

2+ years of experience with medical Quality System regulations
Experience effectively operating with cross-functional team members
Proven experience clearly communicating both verbally and in writing to a multitude of audiences
Master’s degree in Quality Systems or Regulatory Affairs
Project management experience – developing project plans and managing projects to the established plan
Database experience (SAP, CAPA Trackwise, Agile)
Ability to drive actions and provide clarity in ambiguous situations
Customer Service business specific process knowledge
Able to set priorities and execute in a fast paced environment
Ability to drive change in the organization

Senior Quality Systems Specialist Resume Examples & Samples

Coordinate with QSC, Information Technology, project team members, staff and software third party vendor to implement, modify and maintain the eQMS (SOLABS QM10) that includes modules for Document management, Training, OOS, Deviation, Change Control, Corrective and Preventative Actions (CAPA), Product Complaints, and Audits
Accurately and effectively execute standard system administration activities; such as, but not limited to custom list maintenance, role / permission management, system configuration changes
Act as the system Document Control Coordinator; enabling timely and accurate development, deployment and maintenance of controlled documentation through the Document Change Control Process
Act as the system Training Coordinator; enabling timely and accurate identification, assignment and maintenance of training requirements within the system
Leverage system knowledge and pragmatically apply appropriate tools to identify, investigate, and resolve issues. Ensure and facilitate timely issue escalation as appropriate
Provide accurate incident tracking and monitoring, including user support requests, to enable effective and timely resolution
Proactively provide suggestions for solutions to system and /or process issues, and collaborate with appropriate Quality and cross-functional stakeholders to drive execution of technical solutions
Execute system improvements, including performing risk/impact assessment of proposed changes, and drafting or approving system Change Requests as needed. Complete other related system administration work to support implementation of approved changes
Generate and communicate applicable system metrics and reports, fulfilling scheduled and ad-hoc requests, for users, managers, and Quality Compliance Committee (QCC) or similar governance bodies
Employ active listening skills, elicit user feedback, and develop good internal customer relations to promote end user satisfaction and system adoption
Train system users on the use of the software based eQMS processes, procedures and best practices
Demonstrate appropriate situational response when unexpected technical or other assistance is needed
Identify, generate and deliver education, tools and tips to support and enhance user acceptance
Participate in the identification, writing, implementation and maintenance of policies, procedures, and work instructions that support the effective and efficient use, control, and maintenance of the eQMS system
Provide general Audit and Regulatory Inspection support as a part of Ironwood’s Inspection Team. Additionally, support GxP audits and Inspections as a system SME and providing necessary Quality System reports to fulfill requests

Quality Systems Specialist Resume Examples & Samples

Executes the strategic direction for Quality Systems Excellence Programs & Deployment Management. Understands system capabilities, evaluates improved opportunities for management of GXP data, identifies the vision for electronic quality systems and establishes and executes plans to realize this vision
Partners with Information Technology department on quality objectives related to enterprise systems. Serves and the Quality project leader and centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are configured to meet established requirements, test scripts are documented and executed and systems are properly validated to meet regulatory requirements
Creates standard informatics methods for introducing, updating, tracking and trending Quality Systems Metric. Provides standard capabilities for storing information relevant to programs for which Quality Compliance is accountable
Develops the infrastructure to consistently maintain and retrieve informatics and analytics. Enables the identification of the components that make up the data sources and data sets in order to more accurately set internal Quality Systems Metrics Objectives. Ensures that standard reports are available from enterprise systems to track, trend and monitor quality metrics
Ensures that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements (FDA, CGMP, QSR, ISO, CMDR, MDD, etc)
Supports B. Braun affiliates on enterprise system quality matters, as required
Serves as a key quality systems expert to functional business units and Quality Operations
Data analysis; Understanding of informatics and analytics quality systems
Motivation methods
Knowledge of budgeting principles and general administrative practices
Thorough knowledge of management principles and supervisory practices
8+ years of experience with SAP operating systems and SAOP programming and technical knowledge
8+ years of developing Quality systems infrastructure or centralized processes experience in the medical device / pharmaceutical industry
5+ years experience in a quality role
Working knowledge of all quality systems and regulatory requirements in the medical device and pharmaceutical industry
Leadership in partnering with Operations, R & D, Engineering, Sales and Marketing
Ability to use sound scientific judgment in end-to-end value streams (R&D, supply chain, product realization, PLM)
Understanding of cGMP’s and an ability to interpret regulatory requirements
Ability to use sound scientific judgment in management of the e-systems to ensure regulatory requirements and expectations are consistently met
Project Management experience is required
Experience in project creation, team development, and strategy is required
Project Management experience is required, including project initiation, team development, and achieving desired results on time and on budget
Experience building virtual teams globally and enterprise wide with the different business and functional groups and quality operations partners, in order to establish the organization of the future
Advanced degree (M.S., M.B.A.)

Quality Systems Specialist Resume Examples & Samples

Design and Development: Initiate, design, develop and optimize manufacturing and supporting processes to achieve unit objectives
Execute project tasks related to supplier and quality management system development, improvement programs, and/or projects involving departmental, cross-functional, and cross business unit teams
Assist with the global rollout, development, training, and support of enterprise supplier and quality management processes and tools, including EtQ Reliance
Identify continuous improvement and optimization opportunities within the scope of K-C supply chain process capabilities and participate in their prioritization, implementation, and completion
Assist with the ongoing support, development, and improvement of core SRM and SQM capabilities including, but not limited to Contract Management, Supplier Corrective Action Requests (SCARs), Supplier Qualification, Supplier Performance Scorecards, Approved Supplier Lists, and Supplier Collaboration
Ensure changes to existing quality processes meet customer and regulatory compliance requirements
Provide technical leadership and expertise to support large complex facilities, facilities producing highly regulated products and/or corporate staff teams
Bachelor’s degree in a science, business, engineering, or related discipline
Five or more years broad experience in a Procurement, Quality Assurance, Logistics, Manufacturing, Information Technology, or Continuous Improvement function
Process design, development, and improvement proficiency
Solid background of technical knowledge and experience combined with the proven ability to participate in or lead projects, and influence people at all organizational levels
Problem root cause analysis – demonstrated proficiency

Senior Quality Systems Specialist Resume Examples & Samples

Provide quality systems/software systems support to manufacturing, quality assurance, regulatory affairs, product development, packaging engineering and project teams as needed
Support supplier and formula maintenance activities for all business units
Work with software system administrators to insure maximum system uptime, data integrity and efficient workflows
Work cross-functionally to identify opportunities to streamline business processes and associated technical system workflows
Identify and act on opportunities to remove redundancies, non-values added information and standardize data in technical software applications
Support functional needs of corporate Quality Systems/Spec Team, corporate Quality Assurance and Regulatory Affairs
2-4 years of Food Quality, Food Processing experience (with an Information Systems degree)
2-4 years of Information Systems administration, configuration (with a Food Science degree)
Experience with MasterControl, ProductVision, TraceGains preferred
HTML, Visual Basic, C+ programming and report writing experience desirable
Sound Knowledge of basic Food Science/Manufacturing
Technical writing/specification development experience desirable

Quality Systems Specialist Resume Examples & Samples

Serve as a Site Administrator/Sub-Administrator for the EQMS,(onsite and additional business units), including but not limited to access set up, setting up of new users, ongoing trouble shooting, QMS application patch fixes, configuration of new processes and BU’s
Analyse and co-ordinate the development of new process flows to support the continuous improvement activities in NorthStar and transfer of process onto Master Control
Understanding of software Validation requirements with respect to GAMP guidelines, and the requirements of Annex 11 and 21 CFR Part 11
Conduct GMP training as required, including roll out of Multi disciplinary cross training and training on the electronic QMS
Develop templates and write/edit validation documentation as required
Support Qualification process for the EQMS projects,
Track and resolve exceptions during qualification activities and
Prepare reports of executed protocols for review
Assist in ensuring Quality System Procedures/Policies are updated and complied across different departments
Assist in the development and/or appraisal of systems for tracking, trending and reporting of Quality Metrics
Work closely with Information Technology, Quality Assurance and system owners to effectively and efficiently implement system upgrades, or system modifications
Keep Quality Systems Manager and team updated on issues and actions which impact the business
Participate in regular team project meetings
Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and preparation for and/or conducting internal audits
Assist in the Change Management process– ensuring compliance with approved procedures and providing oversight on the performance of the management of change process including the electronic application used to support same
Employ technical expertise, skills, knowledge and experience to assist and /or lead the NH team in the review, closure of investigation reports and CAPA’s
Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required
6+ years pharmaceutical experience in a progressive multinational organization. Minimum 4 years in a Quality Assurance role
Experience of electronic QMS in an established QA function within pharmaceutical/healthcare industries
Working knowledge of GAMP5, 21CFR Part 11, CSV, Project Life Cycle and GxP Regulations
Previous experience in CSV projects while not essential is desirabe
Experience in drafting and reviewing validation documentation
Excellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organization
Ability to work independently and make decisions based on judgement and integrity
Proven analytical skills and ability to transfer findings into report and presentation formats
Excellent organisational skills with the ability to prioritise and manage projects within a team environment
In-depth knowledge of cGMP standards and Quality Management Systems
Experience/Qualification in Root Cause Analysis. e.g. six-sigma Yellow/Green belt

Quality Systems Specialist Resume Examples & Samples

Production Batch Record review and disposition
Lead Routine and annual compliance inspections
Primary source for compliance guidance to production team
Quality Assurance experience within USDA, FDA or, similar regulated facility
Strong knowledge of quality management systems
Proficient at electronic tracking systems such as Trackwise or similar
Skilled in investigation, risk assessment and root cause analysis
Possess a high degree of problem solving ability and critical thinking

Quality Systems Specialist Resume Examples & Samples

Assist in developing and executing upon a process for standardizing QMS in SGBG
Lead and/or participate on Business Process Redesign projects to optimize the efficiency and efficacy of QMS processes
Manage Personal Safety Division's QMS including acting as Lead Internal Auditor
Participate on teams to support Corporate Quality or Business Transformation Quality Management projects, as needed
Train / coach division and plant teams on quality process execution and quality system usage
Minimum of three (3) years combined experience in a Quality and/or Manufacturing environment
Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics discipline from an accredited university
Minimum of five (5) years combined experience in a Quality and/or Manufacturing environment
American Society for Quality (ASQ) certified or willingness to obtain
Experience in managing division or business-group level QMS
Experience in leading internal International Organization for Standardization (ISO) audits
Completed Lead Auditor training on ISO 9001:2015
Experience in utilizing PLM, eNovia, eMatrix (applies to internal applicants only) and/or SAP® Learning Solution (LSO)
Experience in leading Lean Six Sigma Green Belt projects and/or Green Belt certified
Experience in delivering QMS process or quality system related training
3M Global Terms of Use and Privacy Statement

Quality Systems Specialist Resume Examples & Samples

Prepares and maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Conducts quality source selection and process reviews of suppliers' ability to meet program quality requirements and support business decisions, and develops a coordinated response for management review and approval
Conducts hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements and reports results to management
Analyzes data to provide material review dispositions for nonconforming materials, parts and equipment. Works under general direction
More than 1 year of experience in Root Cause Corrective Action (RCCA) and Corrective Action Preventive Action (CAPA)
More than 1 year of experience in Excel (i.e. formulas, pivot tables, linking worksheets)
Experience using Access databases
Experience with command media coordination and/or process and procedure development
Experience with Plan-Do-Check-Act (PDCA)

Quality Systems Specialist Resume Examples & Samples

Performs other duties as necessary
BS degree, or equivalent work experience in the engineering or business field. ASQ certification is preferred with understanding of advanced quality engineering practices, principles, processes, etc. Previous experience in automotive industry is also preferred
Demonstrated ability to communicate with internal personnel to organize information and projects
Demonstrated knowledge of AIAG Core Tools and TS16949/IATF16949 requirements as related to their duties
Demonstrated organizational, project management, and leadership skills to prioritize, coordinate projects, manage conflicting needs, and deal with many issues at one time. Must be able to work independently
Demonstrated strong written and verbal communication skills in order to effectively communicate with internal and external contacts and represent the company in a professional manner when performing job duties. Must have excellent interpersonal skills to exercise influence at various levels and functions
Strong computer background with ability to develop formulas and link fields/pages/workbooks, calculate and analyze data, generate reports, present information, etc
Must possess knowledge of Magna Mirror documentation
Associate will need to be flexible with work hours, and open to limited travel as needed

Quality Systems Specialist Resume Examples & Samples

Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines
Detail-oriented and ability to multitask
Strong interpersonal skills are necessary to operate in a team environment to interact with multiple departments under a variety of conditions
Microsoft Office applications including Word and Excel are required. SAP and Visio experience is a plus
Minimum of High school diploma or equivalent. Associate degree or equivalent in Biology, Chemistry, or related field preferred
0-2 years of relevant experience in document creation and managing Document Control functions within a document management systems and product life cycle systems. 2+ years of relevant experience preferred. Strong technical writing background is a plus
Preferred candidates should have experience working under FDA regulations and ISO standards
Basic understanding of GMP and quality system standards desirable

Quality Systems Specialist NDE Resume Examples & Samples

Supports, oversees and/or leading the Nondestructive Inspection (NDI) processes on the Space Launch System (SLS) program
Quality reviews of proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development
Leads Quality reviews of proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development
Leads multi-function, multi-site groups to develop company directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Conducts quality source selection and process capability assessments of suppliers' ability to meet program quality requirements and support business decisions
Develops Quality criteria for supplier source selection and a coordinated response for review and approval by senior management
Analyzes data to provide material review dispositions for complex nonconforming materials, parts and equipment
Current Ultrasonic NDE Certification (Level 2 or Level 3)
More than 3 years of experience in NDI (non-destructive inspection) or NDT (non-destructive test)
More than 3 years of experience in MRB (Materials Review Board) and/or corrective action experience
More than 3 years of experience using Phased Array Ultrasonic Testing (PAUT)
Current American Society for Quality (ASQ) Certifications (CQA, CQE and/or CQT)

Quality Systems Specialist Resume Examples & Samples

More than 5 years of Quality experience
More than 5 years of experience performing product, process or compliance audits of Quality Management Systems
Experience in NASA Space programs or a related Space or Defense program
More than 5 experience in MRB (Materials Review Board) and/or corrective action experience

Senior Quality Systems Specialist Computer Systems Resume Examples & Samples

Author and implement corporate and local policies and procedures pertaining to computer system validation and change control
Define standards to ensure compliance with FDA requirements for computer system validation and 21 CFR Part 11 compliance
Provide technical guidance and supervision to computer system validation engineers at multiple B. Braun U.S. facilities
Author or review procedures and policies pertaining to computer system validation, system life cycle maintenance, IT policies and operations
Author or review validation documentation for specific computer systems, equipment/process control systems and computer networks, to include validation plans, system requirements, design and validation protocols/reports
Supervise and otherwise manage personnel and contractors involved in computer and control system validation
Provide guidance to B. Braun U.S. and Global operations concerning computer system validation requirements and standards
Review regulatory rules and guidelines pertaining to computer systems and electronic data and determine their impact on B. Braun U.S. operations. Stay current with FDA requirements for these rules
Perform and close out audits of computer system, software and service suppliers based on recommendations in a timely manner
Act as QA Lead in specific computer-related projects at B. Braun U.S. including quality, laboratory and manufacturing systems. Manage ongoing validation efforts to establish compliance, and quality through CSV (computer system validation) frameworks
Plan validation activities and staffing requirements for computer system projects
Train computer validation engineers and other B. Braun personnel in FDA computer validation requirements and internal procedures related to computer system validation and change control
Interface with personnel both within and outside department, external contractors/consultants, customers and government agencies
Decision making capability when hiring of staff under quality, IT and computer systems requirements
Solid understanding of the efficiencies and criticalities of all of the quality systems elements at BBMI. Work seamlessly with functional business groups to improve upon vertical and horizontal system interfaces and efficiencies
Executes the strategic direction for Quality Systems Excellence Programs & Deployment Management. Understands quality and regulatory requirements and integrates these within the company’s Quality Management System in accordance with system capabilities. Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations
Partners with Quality Operations at all BBMI sites on quality objectives related to quality systems and processes. Serves and the Quality project leader and centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively executed to all affected personnel prior to implementation
Implements and maintains the Corporate Operating Procedures and centralized processes and templates, identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems integrated
Analyzes metrics and informatics to monitor the BBMI quality system and its compliance across all sites. Identifies system and process issues, concerns or improvement opportunities and leads resolution
Responsible for executing the long-term strategy of the Company’s Quality Systems, incorporating best practices while maintaining alignment to Company Objectives
Ensures that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements (FDA, CGMP, QSR, ISO, CMDR, MDD, GAMP5, etc)
Keeps informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company’s Quality Systems
Experience with quality assurance standards such as ISO, ICH, USP & GxP is preferred
Data analysis; Understanding of informatics and analytics of quality systems
Statistical sampling methods,
CGMP’s, QSR’s, ISO, CMDR,MDD, and GAMP5
Quality Risk Management process and tools
8+ years of developing Quality systems infrastructure or centralized processes experience in the medical device / pharmaceutical industry and experience in managing CSV validation efforts to establish compliance and Quality
5+ years experience in a quality leadership role required
Cross Functional Team Leadership in partnering with Operations, R & D, Engineering, Sales and Marketing
Experience in FDA inspections and strategy, cGMPs and an ability to interpret regulatory requirements
Ability to use sound scientific judgment in management of the facility to prevent regulatory action
Ability to understand and evaluate end-to-end value streams (R&D, supply chain, product realization, PLM)
Demonstrated track record in managing a diverse staff and establishing a clear, strategic direction
Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment
Experience with equipment controlled by ERP, LIMS, EDMS, MES, ELN/LES, SDMS and other Quality and development laboratory systems

Quality Systems Specialist Resume Examples & Samples

Regularly contributes to the development of new job practices, software quality assurance techniques, and corporate quality standards. Recognized as a job expert within the department/organization
Develops solutions to complex problems that require ingenuity and innovation. Ensures solutions are consistent with organization objectives
Performs work with minimal direction and exercises considerable latitude in determining objectives and approaches to assignment
Effects of decisions are long lasting and heavily influence the future course of the organization. Errors in judgment or failure to achieve results may result in the significant expenditure of company resources
Serves as subject matter expert to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives

Quality Systems Specialist Resume Examples & Samples

Maintain Spacelabs Unique Device Identifier (UDI), Internal/External Audit programs. Identify and execute system improvements, and write change orders as required to ensure compliance to all relevant regulations and standards
Maintain FDA product code lists, as defined by Regulatory Affairs
Maintain GMDN code lists, as defined by Regulatory Affairs
Maintain Global Trade Identification Numbers for all Spacelabs Healthcare products
Maintain GS1 subscriptions
Assist with conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished
Maintain internal audit schedule
Assist Manager with group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met
Uphold the Company’s core values of Code of Ethics and Conduct, and applicable compliance policies
5+ years of experience with medical device regulatory and quality systems or equivalent experience
2+ years of experience as a Lead Auditor or equivalent experience
Lead Auditor certification required
1+ year of Unique Device Identifier experience and/or configuration management desirable
Ability to communicate effectively over the telephone, in person, and in written form; with staff at all levels of the organization. Ability to present to large audiences desirable
Creative problem solving, flexibility, and good negotiation skills
Ability to multi task and drive practical results to a timely conclusion
Self-motivated and organized
Competency in computer skills: MS Office applications, Agile PLM or other medical device quality system application
Travel: Some travel required, both domestic and international <20% Must travel internationally and be able to acquire all necessary travel documents
Must be able to complete job responsibilities working with different time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 15%

Principal Quality Systems Specialist Resume Examples & Samples

Support the Tissue Bank Director in maintaining Wright Medical's Tissue Bank Quality Assurance program and the activities of the Quality Assurance / Quality Control departments to assure compliance with applicable tissue bank standards
Assist with assuring the direction, discipline, and actions of all tissue related activities are carried out according to FDA regulations, AATB standards and international tissue bank requirements (as applicable)
Assure timely and effective execution of decisions and/or recommendations made to executive management by the Tissue Bank Director concerning tissue product retrieval decisions
Support, as requested, systems to assure the proper quality approvals to any change in tissue product design, specification or production process
Support/perform internal Tissue Bank Quality audits: Audit Medical Devices containing human tissue as defined by the audit program. Annually, assist with hosting the audit of the entire Tissue Bank operation to assure conformity with tissue related operating procedures, government regulations, and AATB standards. Support external Quality audits: Audit Medical Devices containing human tissue as defined by the audit program
Support the Tissue Bank Director during all inspections by external regulatory agencies pertaining to the Tissue Bank (i.e. FDA and AATB)
Support the communication of Tissue Regulations / Standards changes to the organization as appropriate, including management review
Recognize and communicate issues of liability, ethical considerations, fiduciary responsibility, and compliance with applicable laws, regulations, and the Tissue Bank's SOPM as appropriate. Shall assist with the review of the suitability and effectiveness of the Quality System according to established procedures to ensure that the quality system satisfies regulatory requirements, quality policy and objectives
Must attend at least one AATB meeting/workshop every three years
Ensure all state licenses are obtained and maintain; annual/activity/maintenance fees are paid; and ensure FDA Registrations are renewed and accurate
Ability to be hands-on, results driven and process a sense of urgency. Candidate must implement and manage comprehensive quality strategies as part of a high performing team. Set and maintain high standards for individual and team performance
Must have a strong working knowledge of Tissue Banking to include: recovery, processing, storage and distribution preferably in the medical device industry. Must also have a strong knowledge of FDA regulations 21 Part 1271 and 820 as well as AATB Standards for Tissue Banking with experience hosting external regulatory inspections. Strong knowledge of Health Canada and other international tissue banking regulations
Working knowledge of all aspects of a Quality System to include: change control, label development, internal/external auditing, CAPA, and training methods among others
Experience and ability to plan and manage major projects from inception to completion with a proven track record. Ensure projects are compliant to standards for regulatory and safety agencies (FDA, AATB, State Laws. etc.) and are beneficial to the future direction of the tissue bank
Must be able to work effective as a team member and build cross-functional relationships by working collaboratively with teams including; Regulatory, Supplier Quality, Sales Force, Distribution Centers and others in the organization to ensure tissue bank quality requirements
Maintains and advances skills though professional education and training thereby increasing the effectiveness of the tissue bank
Strong and effective interpersonal skills in order to communicate effectively with direct team members, suppliers and hospital accounts
Proven professionalism and ability to work both independently and as part of a team is required
Associate's degree in life science field required (e.g. biology, biomedical, nursing, etc. ) with a Bachelor's degree preferred. Should have 3-5 years of progressive experience in a tissue bank quality position- preferably in a medical device organization (depending on candidate, experience and/or education may be accepted as an equivalent)
Preferred Certifications/Memberships (Must be willing to obtain within one year of hire date)
Active member of the American Association of Tissue Banks
Certified Tissue Bank Specialist through the American Association of Tissue Banks (CTBS)
Active member of the American Society for Quality (ASQ)
Certified Quality Auditor (CQA) through the American Society for Quality (ASQ)

Quality Systems Specialist Resume Examples & Samples

As CAPA team member, support a wide portfolio of CAPAs to ensure CAPA process compliance, appropriate rigor and timely execution includingÃ¢??
Bachelor’s Degree with 5+ years of experience in the medical device or pharmaceuticals industry
Experience working with non-conformances, and corrective action and preventive action processes
Strong critical thinking and analytical skills
Lean Sigma certified or demonstrated problem solving experience
Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk)
A competitive hourly pay rate with weekly checks
Access to newly expanded Medical Plan options
Online continuing education via the Kelly Learning Center
Several employee discounts
And more!

Pr Quality Systems Specialist Resume Examples & Samples

Proficient knowledge and application of Quality System Regulations and International Standards
Site audit prep activities. Proven skill mobilizing the site ensuring everyone and everything is ready for audit. Skilled at working with external auditors and answering questions
Leads improvement efforts in the change, approval and release of product documentation and data using PLM change process flows, DHF, DMR, part numbers and product identifiers, Bill of Material (BOM), manufacturing & material specifications, and document archiving with general direction
Evaluate and recommend changes to current systems. Serve on multi-business teams to evaluate system changes/upgrades. This includes having the necessary skill sets to lead continuous improvement projects
Support the development and implementation of Quality System procedures, Quality System software, and Quality System training programs
Provide expert guidance in interpreting governmental regulations, agency guidelines and Medtronic internal policies in general
Understands root cause methodologies (fishbone diagram, DMAIC, etc.)
Support internal and external audits and inspections
Ability to educate management in the Audit, CAPA, Configuration Management and Training process areas
Influence management skills
Ability to work constructively across all functions/level of the organization as well as external customers and regulators

Senior Quality Systems Specialist Resume Examples & Samples

Solid knowledge and application of Quality System Regulations and International Standards
Site audit prep activities. Assist in mobilizing the site ensuring everyone and everything is ready for audit
Experience working with external auditors and answering questions
Evaluate and recommend changes to current systems. Serve on multi-business teams to evaluate system changes/upgrades
4+ years of Quality Systems experience with a Bachelor's Degree
Understanding and application of global quality system requirements and relevant standards for medical device/combination device industry
Understanding of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, etc
Effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Experience with MDSAP paradigm
Ability to educate in the Audit, CAPA, Configuration Management and Training process areas

Quality Systems Specialist Resume Examples & Samples

Ensures Quality System conforms to the Quality System Regulations (QSR), ISO 13485, MDD, CMDR, PAL, corporate and sector requirements
Assists with the implementation of Quality System Improvements in conjunction with Quality System Manager and Director of Quality
Prepares and completes of Document Change Orders including training as requested
Manages the system for implementing changes to Quality System procedures based on the implementation of Sector SOP and Corporate Policy changes
Plans, coordinates, and presents Quality System training and/or new employee quality system orientation training including Complaint Handling Awareness
Compiles Quality System trend data, prepares presentation of the data at Quality Review Meetings and coordinates Quality Review and Quality Management Review meetings
Prepares monthly sector metrics for CAPA, Environmental Monitoring and other Quality System processes as requested
Creates and maintains Quality System files and databases to ensure information is accessible and accurate (ex. CAPA Tracking Log)
Supports and coordinates corporate, internal, and external regulatory agency audit activities as assigned
Monitors and tracks the implementation of corrective action/preventive action (CAPA) as result of internal and external audits (FDA, TUV, etc.) and reports progress to management on a routine basis
Serves as the CAPA Coordinator, as assigned, providing general guidance of CAPA activities and documentation to assure compliance with CAPA policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at each CAPA process phase
Participates in CAPA activities such as root cause analysis, corrective action plans and effectiveness verifications
Enters and updates data within the CAPA database, providing routine status reports and updates on current CAPA system activities to management on a routine basis
Assists with the Product Experience Reporting process activities including submission of MDRs (Medical Device Reporting) and closing of complaint file closures as needed
Performs data queries in the Complaint Handling Database to support complaint investigations and management requests
Assists with sending out test samples as needed to support routine bio burden testing
Assists with post distribution activities such as Product Holds and Field Corrective Actions per procedures
Facilitates and supports Recall Review Committee Meetings as required
Identifies areas for improvement in Quality System SOPs and Forms and implements changes
Works closely with SOP Document Guardians to ensure that changes to procedures are adequately identified to ensure affected procedures and forms accurately reflect the represented process and are in compliance with applicable regulations and standards
Demonstrates solid technical proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources acting as a resource to other sites
Applies statistical methods in support of tracking/trending of data and in problem solving related to the development and application of solutions to CAPAs and other quality system activities
Travel requirement: 0%
3+ years QS or QC related experience in FDA/GMP regulated industry including involvement with internal/external auditors
2+ year general laboratory experience
BS/BA degree preferably in Engineering or Life Sciences
Working knowledge with the handling of bio hazardous materials preferred
Working knowledge of laboratory analytical methods and techniques
Excellent computer skills to navigate various systems and investigate the complaint records as needed. Examples of systems include: SAP and Trackwise
Proficient with computers to conduct through complaint investigations and research
Excellent working knowledge of MS Word, Excel and Power Point
Excellent verbal and written communication skills, including the ability to develop and present technical information necessary for the company
Excellent communication and follow-up skills to investigate and seek additional information for complaints
Consistently demonstrates ability to manage multiple tasks and complete daily work schedule actions in a timely manner
Demonstrates proficiency to read, train to and apply all the regulatory requirements for Complaint Handling and Medical Device Reporting
Exemplifies ability to work in a team environment and foster team work
Ability to demonstrate a high standard for accountability, work ethic and dedication to tasks and assignments
Good problem solving and investigation skills
Good critical thinking skills
Good analytical skills including ability to analyze/identify problems and recommend solutions
Working knowledge of FDA 21CFR 820, 803; ISO 13485, Medical Device Directive and applicable Harmonization Standards that apply to medical devices desired

IHS Quality Systems Specialist Resume Examples & Samples

Maintenance and improvement activities regarding the IHS Quality Management System
Collect and prepare information for Management Reviews
Complete quality activities during service activation including the realization of Quality Assessments
Prepare and/or support internal functions with the delivery of performance reports for the unit
Participate in service delivery monitoring activities (e.g.; creation and maintenance of dashboards)
Perform supplier quality related activities
Preparation activities concerning external (e.g.; Certification/Notified Body) and corporate audits at IHS premises
Be part of the IHS Auditors’ pool and/or lead internal audits applicable to internal processes and customer account activities
Support Process Owners/delegates with maintenance / update of QMS documentation
Monitor the Complaint Handling and Corrective Action (CAPA) systems and identify root cause analysis and propose improvements
Organize and execute risk assessments concerning unit processes and customer account processes
Analyze and monitor customer feedback
Perform quality awareness trainings and quality communication activities
Participate in service quality reviews as requested by QA management
Experience in the medical devices industry, healthcare and/or service/solution-oriented environments
Experience of supplier quality management including supplier selection, supplier auditing, supplier monitoring and issue resolution
Knowledge of international quality standards and regulations (e.g. FDA 21 CFR 820, ISO 9001, ISO 13485, Joint Commission International…)
Knowledge of risk management/assessment techniques (e.g.; FMEA)
Quality Auditor experience
Min. 5 years of relevant quality working experience in medical technology, logistical and operational environment or healthcare service environment
Experience in international business, multinational and complex environments
Ability to read, express and report in fluent English and German. Additional language skills are a plus
Analytical ability & practical approach; problem-solving
Good communication/presentation skills

Principal Quality Systems Specialist Resume Examples & Samples

Bachelor’s degree with 7+ years of experience in quality and/or regulatory OR Master’s degree with 5+ years of experience in quality and/or regulatory
Working knowledge of Field Action regulations and expectations, including 21 CFR Part 7 and Part 806
Experience working in the medical device industry
Experience leading global projects with cross functional teams and facilitating meetings with senior leadership

Senior Quality Systems Specialist Resume Examples & Samples

Establish and conduct Investigation and Root Cause analysis to ensure nonconforming product incidences are investigated and prepare recommendations for CAPA
Assist the Quality Review Board with CAPA processes and CAPA feeder processes (Examples: NCMR, Customer complaints)
Partner with Quality Engineering or Manufacturing Engineering to assist in developing test methods, validations/qualifications, process monitoring, statistical analysis of data for significance, risk assessment, and other documented requirements for quality objectives
Evaluate and approve document changes for existing products and processes, monitor design developments for maintaining quality compliance and assists in testing and validation
Develop / revise, and evaluate document changes for procedures, products and processes to maintain quality compliance and for improvement to the Quality Management System
Assist with leading activities to investigate and understand product quality issues and quality management system (QMS) compliance issues
All activities must be performed in compliance with the Quality System
Travel requirement: Less than 10%
4+ years experience with a Bachelors degree or equivalent experience
No specialized knowledge required
Excellent oral and written communications skills
Ability to self-direct (minimal supervision), self-starter and multitask
Exceptional interpersonal and negotiation skills and ability to cultivate positive relationships with co-workers in a cross functional and cross facility environment
Proficiency in MS Excel, MS Word, MS PowerPoint, MS Outlook; MS Project and Minitab or similar is a plus
During the course of regular assigned duties, the employee may be required to properly utilize clean room garments and personal protective equipment including but not limited to: safety shoes, safety glasses, goggles, and hearing protection
The employee must be able to lift 20 pounds per job requirement
Workspace is office cubicle. Other conditions apply in manufacturing facility as described in the section above

100

Quality Systems Specialist Resume Examples & Samples

Strong project management, organizational and problem solving skills
Manages through influence on projects; guides and directs others while being results oriented and a project leader
Performs and writes failure investigations
Identifies root cause, corrective/preventive actions, and participates in execution of field actions
Leads investigations related to quality problems
Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations
Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary
Bachelor’s/Master’s degree in STEM
Engineering experience
Ability to make and present quality decisions
Ability to systematically manage multiple projects simultaneously from initiation through closing phases
Specific specialized engineering skills in analyzing and optimizing manufacturing and quality systems
Ability to apply comparative statistics
Demonstrated ability to create and execute project plans
Knowledge of Quality System Regulations (FDA, ISO13485)
Self-motivated, able to accomplish multiple assignments simultaneously
Demonstrates a high degree of accountability
Strong project management, organizational, and problem solving skills
Ability to lead, influence, negotiate, and work with multiple departments and sites
Demonstrated competency in computer skills: MS Office applications
Comfortable in a high-stress environment
Demonstrated ability to communicate effectively over the telephone, in person, and in written form
Must be able to communicate appropriately and adequately to all management levels, including public speaking and group presentation experience

101

Quality Systems Specialist Training & Technical Publications Focal Resume Examples & Samples

Managing training (identifying, scheduling and recording) for a busy part 145 maintenance organisation
Maintaining the training matrix and required records (soft and hardcopy)
Highlighting upcoming training requirements for all personnel
Supporting the authorisation process for Engineering, Quality and Stores personnel
Managing locally controlled Technical Publications
Managing and distributing Technical Documentation from Customers, Boeing and other applicable entities
Preparing reports relating to status of training and technical publications as necessary
Supporting audits and investigations (internal and external) of BIL training and technical publications
Developing and improving procedures for training and technical publications
Working as part of a local and wider team (Boeing and/or customer)
Important information regarding this requisition: This requisition is for an international, locally hired position. IT IS NOT FOR AN EXPAT ASSIGNMENT. Benefits and pay are determined in line with local country labor market practices. Please list all of the Countries in which you are a citizen and/or have work authorization for on the top of your resume. Candidates will need existing rights to live and work in the UK in order to be considered for this role.**
Must have a strong level of computer literacy
Have proven experience of managing data and records
Experience of scheduling activities
Good teamwork ethic
Strong preference will be given to candidates from an aviation maintenance environment
Experience of using Q-Pulse (compliance management system) is particularly welcome

102

Quality Systems Specialist Resume Examples & Samples

Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad
Detailed oriented and ability to multitask
Decision making, time management, organization, communication, and leadership

103

Quality Systems Specialist Resume Examples & Samples

Must have the ability to perform due-diligence in writing Complaint Investigations
Analyze quality data & prepare reports
Make recommendations and present the information to an audience
Develop technical and procedural knowledge in Apheresis
Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques
Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques
Continuous development of knowledge in physical, life sciences, or engineering theory and practice as this knowledge applies to each project
Knowledgeable in FDA and international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO
Work assignments require the development of in-depth engineering or technical skill(s) or breadth
Knowledge of relevant PC software applications and skills to use them effectively. Proficiency in MS Excel with the ability to create reports, charts and pivot tables

104

Quality Systems Specialist, Facilities Resume Examples & Samples

Contribute to the day to day operation of the Facilities group as a technical resource to aid in completing Quality systems commitments
Execute work in Quality systems (Trackwise, Documentum, etc)
Coordinate routine project status updates for the Maintenance team
Support inspection/audit activities by providing tours, responding to audit requests and/or observations
Develop and train staff
Several years of experience in a Biotechnology Quality role or a related field as well as in cGMP and technical experience
Must have a sound understanding of Quality Systems and supporting documents’ requirements in a regulated industry, be well organized and have excellent time management skills. Attention to detail and cGMP experience are required
Well-developed computer skills are required; applications such as MS Office and SAP CMMS are used on a continual basis. Excellent verbal and written communication skills and the ability to motivate and train staff

Download Quality Systems Specialist Resume Sample as Image file

Related Job Titles

Quality Assurance Specialist Resume Sample

Quality Specialist Resume Sample

Quality Systems Manager Resume Sample

Data Quality Specialist Resume Sample

Clinical Quality Specialist Resume Sample

Senior Quality Specialist Resume Sample

Quality Systems Analyst Resume Sample

Manager, Quality Systems Resume Sample

Director, Quality Systems Resume Sample

Compliance / Quality Specialist Resume Sample

Quality Systems Resume Sample

Quality Management Systems Resume Sample

Browse More

Quality Systems Specialist Resume Samples

The Guide To Resume Tailoring

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Resume Builder

15 Quality Systems Specialist resume templates

Read our complete resume writing guides

How to Tailor Your Resume

How to Make a Resume

How to Mention Achievements

Work Experience in Resume

50+ Skills to Put on a Resume

How and Why Put Hobbies

Top 22 Fonts for Your Resume

50 Best Resume Tips

200+ Action Words to Use

Internship Resume

Killer Resume Summary

Write a Resume Objective

What to Put on a Resume

How Long Should a Resume Be

The Best Resume Format

How to List Education

CV vs. Resume: The Difference

Include Contact Information

Resume Format PDF vs Word

How to Write a Student Resume

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Advanced Quality Systems Specialist Resume Examples & Samples

Medical Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Auditor Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Capa Quality Systems Specialist Resume Examples & Samples

Senior Capa Quality Systems Specialist Resume Examples & Samples

Principal Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Principal Quality Systems Specialist Resume Examples & Samples

Principal Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Principal Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

Senior Quality Systems Specialist Resume Examples & Samples

Quality Systems Specialist Resume Examples & Samples

How to Make
a Resume

50 Best
Resume Tips

200+ Action
Words to Use

Internship
Resume