Quality Systems Manager Resume Samples

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C Stokes

Cletus

Stokes

3744 Gustave Estate

San Francisco

+1 (555) 114 0899

3744 Gustave Estate

San Francisco

Phone

p +1 (555) 114 0899

Experience Experience

Phoenix, AZ

Quality Systems Manager

Phoenix, AZ

Olson, Will and Okuneva

Phoenix, AZ

Quality Systems Manager

Develop, manage, and continually improve Quality Assurance programs, policies, intranet applications and databases
Review and/or develop and execute facility, software, process and equipment validations and risk management documents
Work closely with the management team to support the growth and development of NorthStar
Develops, maintains and execute the site wide strategy for Deviation Management Excellence, including Root Cause Analysis, CAPA, and Technical Writing programs
Identifying and recommending to senior management areas for improvement in the quality management system and the wider company at large
Perform other work-related duties, as assigned by site management
Work with the local management team members in developing long and short-term business goals and strategies

Los Angeles, CA

Senior Quality Systems Manager

Los Angeles, CA

Smith-Schmeler

Los Angeles, CA

Senior Quality Systems Manager

Leading continuous improvement of Siemens Molecular Imaging Quality Management System through the implementation of robust Internal Audit and CAPA programs
Process owner for the Internal Audit program and procedures. Working on enhancing the efficiency and effectivity of the Internal Audit program
Develop & maintain the Quality plan and metrics
Provide oversight and maintain the Quality System
Participate in the preparation and execution of site and BU management reviews
Tracking implementation of corrective actions and performing effectiveness verification activities related to audit findings
The noise level in the work environment is usually quiet to moderate

present

Houston, TX

Senior Corporate Quality Systems Manager

Houston, TX

Runolfsson, Jakubowski and Johns

present

Houston, TX

Senior Corporate Quality Systems Manager

present

Create and deliver training presentations
Collect and report on trends/metrics to proactively identify areas for improvement
Perform ISO 9001 and other ISO process audits to determine business effectiveness, and implement and maintains ISO 9001 compliance for R&D
Analyze current state and work with functional leaders and define business processes to meet defined business objectives
Transform new designs to standardized work with assigned responsibilities
Update, maintain and publish Audit Calendar; and organize and manage the process
Manage, maintain and enforce internal audit control policies across the enterprise

Education Education

Bachelor’s Degree in Engineering

Duke University

Bachelor’s Degree in Engineering

Skills Skills

Knowledgeable in industry Food Safety/Quality audit practices, and skilled in adapting to achieve business best practices
Strong authorship and be able to critically review reports while effectively providing input and expressing Quality Risk management principles
Excellent knowledge of quality management systems
Experience in managing Quality Assurance and quality systems in FDA and HPRA based Pharmaceutical manufacturing essential
Knowledge of IT technologies and their application to Quality Assurance objectives/programs
Excellent organisational skills and attention to detail
Capable of successfully engaging other business unit quality in the development and standardization of programs, policies, templates, standards, procedures
Strong strategic vision/ability; Skilled at aligning business plans with strategic objectives
Ability to manage multiple responsibilities with urgency via strong project/event management skills
Ensures group is technically capable of handling non-routine quality system issues and that issues are thoroughly investigated, documented, and resolved

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Quality Systems Manager Resume Examples & Samples

Bachelor’s degree and 7+ years of cross functional responsibility in CSV in Quality Systems
Excellent understanding of GXP and pharmaceutical regulations
Experience in the validation of software tools in a FDA regulated environment
Knowledge of regulations and software lifecycle approaches 21 CFR Part 11, Annex 11, risk management methodologies, GAMP, SDLC methodologies
Working knowledge of auditing and validating SaaS applications in a GxP environment
Working knowledge of global industry standards and regulatory requirements for quality systems
Experience in interacting with FDA and International regulatory authorities
Proficiency with MS Office and software programs for generating reports, presentations and statistics
Working knowledge with TrackWise, EBS, Argus, etc
Excellent planning and organizational skills required
Experience with parenteral drugs

Quality Systems Manager Resume Examples & Samples

Bachelor's degree in chemistry, biology or a related discipline (or an equivalent combination of education and relevant experience)
Extensive experience (5 to 10 years) working in Quality supporting the manufacturing of drugs, biologics, or devices in the pharmaceutical/biotechnology industry
Previous Quality and/or project management experience of the revision of the Quality Management System (Quality Manual and Quality Standards/Policies) preferred

Quality Systems Manager Resume Examples & Samples

Manage daily activities related to the QMS
Create and improve the supplier evaluation and qualification process
Promote and support business excellence, lead by example, develop partnerships internally with the required business functions
Ensure all new artwork and new products are in line with standards and ensure full adherence to production quality throughout the manufacturing process
Represent the company to all external bodies
Conducting Internal and External audits where required
Preparing monthly quality reports, vendor ratings and management reviews
Liaise with Manufacturing Engineers to conduct risk assessments and ensure all work instruction updates for any product line extensions, process improvements for new and existing products are delivered effectively
Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates internal to colleagues and external to regulatory bodies
Extensive experience managing the QMS
Degree in Engineering or Science
Minimum of 4 years' experience in a Medical Device environment, ideally in a similar role managing all standards via the QMS for quality and regulatory
Strong knowledge and exposure of ISO 13485 standards and regulations
Strong exposure with problem solving techniques and working through CAPAs'

Quality Systems Manager Resume Examples & Samples

Actively support the management of site Quality Systems
Manage implementation & maintenance of Corrective Action, Preventative Action & Change Control
Quality Systems Auditing to assure compliance to GMP and support site audit readiness activities
Point of contact for all customer issues, queries or complaints as well as internal contact point for customer services, commercial, Department of Agriculture
Status report metrics for the CAPA and Change Control systems and other relevant KPIs
Co-ordination of quality related documentation for auditing (collation, filing, storage, presentation)
Support process and product validation and compliance activity
Documentation management and ownership of the document library
Status report metrics for documentation lifecycle management process
Ensure quality risk management documentation is complete and maintained
Administrate the records retention program
Drive Continuous Improvement of Quality System processes
Support training on site document management and Change Control systems
Support subject matter experts to create training material/programs
Develop and review documentation as appropriate
Execute local mock recall exercise
Compilation of the Master Manufacturing Batch Records for compliance to cGMP

Quality Systems Manager Resume Examples & Samples

Lead the HACCP team and ensure the HACCP platform is in place and maintained
Ensure the technical policy, procedures and monitoring documents are in-place, maintained, document controlled, communicated, understood and reviewed
Ensure customer technical requirements are reviewed and interpreted and communicated to the site teams and any gaps identified are communicated and actioned
Review procedures and where necessary generate & implement new procedures
Manage Internal Audit program which meets all legal and customer requirements; ensure it is maintained to schedule, conducted by a trained internal audit team and non-conformance and audit performance communicated
Oversee Production due diligence records
Document Control and Archive Management
Calibration: ensure key equipment is calibrated within timeframes and certificates retained
Ensure all paperwork (documents and procedures) are updated for new products where applicable
Oversee Administration of computer systems including Price Sheets, Label Creation etc
Work with the site teams to ensure the site is audit ready at all times in regards the technical systems and factory standards
Proven experience, with proven results in quality systems role –essential
Experience in Management of HACCP & Quality Systems - essential
People Management skills - essential
Efficient communication skills at all levels - essential
Experience at Auditing – essential
Auditor qualification – essential
Practical Understanding of BRC & Retail Customer Standards – desirable
Degree or equivalent in food related or science based subject – desirable

Quality Systems Manager Resume Examples & Samples

Define, develop and deploy the common set of procedures, tools, methodologies and rules (the “Electrolux Quality Management System”) valid for all Functions and Sectors
Develop, deploy and maintain the common templates required by the “Quality Management System”
Ensure that the Quality Manual defining the ”Quality Management System” is applied consistently throughout each NA Product Line
Set forth a scheduled audit program to ensure the correct application of the above Quality Manual to each NA Product Line
Contribute to define and maintain a common set of Quality kpi’s, cross-functional, to track continuous improvement progress in Quality results
Ensure achievement and maintenance of ISO 9001 Certification in North America, using common approach and Certifier
Promote best practice and learning to ensure continuous improvement of the “Quality Management System”
Academic Degree in Industrial Engineering or equivalent
Master Degree in engineering or operations management\Business (preferred)
5 years minimum experience in activities related to Quality Management Systems, especially related to definition and deployment of procedures and methodologies
Very good knowledge and experience in applying ISO 9001 Quality standards, related to all covered aspects (R&D, Operations, Purchasing)
Plant or Sector quality engineering / process leadership experience
Plant or R&D Experience strongly desired
Proven record of success leading continuous improvement projects and activities
Possess a high sense of urgency with the ability to make and implement tough and timely decisions
Demonstrated leadership capability in communicating and influencing others, stakeholder management, change leader and driving project success individually and through teams
Highly strategic in thought and behaviour, while driving also short-medium execution
Superior mental agility, dealing comfortably and quickly with complex issues
Leader and team player
Strong cooperative approach
Digital attitude
Focused on results with a high sense of urgency
Confidence and courage to champion change
Characterized by integrity and high professional standards
Able to see big picture and work on a strategic level
A passion for analyzing data and making business conclusions and recommendations
A fast thinker with ability to pick up and treat new information rapidly
Multicultural experience
Ability to work independently and produce results
Enthusiastic, energetic and pro-active

Quality Systems Manager Resume Examples & Samples

A minimum of a Bachelor Degree is required, preferably in Engineering, Quality or a related technology field
A minimum of 6 years Quality experience in a GMP and/or ISO regulated environment is required
A minimum of 2 years of supervisory (direct/indirect/project management) experience is required
Experience with CAPA is required
Data analysis and basic statistical tools are required
This position is located in Palm Beach Gardens, FL and may require some travel

Quality Systems Manager Resume Examples & Samples

Cell therapy/gene therapy is highly desired
Experience in a lead role and interactions with federal agencies, i.e. FDA
Expert knowledge of quality assurance in cGMP environment
Knowledge of International Conference on Harmonization (ICH) standards
Experience in developing and implementing multifaceted projects
Excellent communication and organizational skills and superb attention to detail
Experience with MS Office products and database applications required
Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice

Quality Systems Manager Resume Examples & Samples

Bachelor’s degree required (Engineering, Quality, Regulatory or Life Sciences preferred)
5+ years with Bachelors or Basic Degree
3+ years with Masters or other Advanced Degree
3+ years of experience providing work direction and leadership to people and teams in functional area or related field
3+ more years of experience in the CAPA process or Compliance
Knowledge of the US and international medical device quality system regulations and standards (21 CFR 820, ISO 13485)
ISO 13485 Lead Auditor certification (or willing to get within one year)
Regulatory compliance experience with emphasis on Quality System Regulations
MBA or Masters in Engineering, Quality, Regulatory or Life Sciences preferred
7+ years of experience in a medical device quality assurance and/or quality system preferred
Experience with CAPAs and interpreting requirements for non-conformances, quality tools and process improvement techniques
Experience interfacing with government auditing bodies, conducting/hosting quality system audits
Project or program management experience
Good computer skills using Excel, Word, and PowerPoint
Experience leading/managing high performing teams and projects
Experience with Class II and III medical devices
Experience with capital products and field service
RAC or CQM/CQE/CQA/PMP Certifications
Facilitation and training skills
Outstanding oral, presentation, and written communication skills. Ability to communicate / present complex and / or highly detailed issues / information in a way that is understandable cross-functionally and at all levels of the organization
Excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies
Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross functionally
Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment and exert influence without alienating others
Strong task and people management skills

Quality Systems Manager Resume Examples & Samples

Broad knowledge in the following disciplines
HHA / Post Market Vigilance
Equipment Qualifications
Computerized System Validation
Regulations as: ISO 13485, 21 CFR Part 11 and
21 CFR Part 820
In depth statistical knowledge is required

Senior Global Quality Systems Manager Resume Examples & Samples

Ensures collaboration and builds partnerships with stakeholders to execute quality strategies for driving continuous process improvement through the Quality System
Participates in the development and execution of the GCRQA internal system audit schedule, conducts audits, monitors adherence to company policies and reports findings to audited departments for issue resolution
Actively participates in the maintenance of the Corrective and Preventive Action Program. Tracks completion of required corrective and preventive actions as a result of internal audits and External Regulatory Inspection commitments
Develops and utilizes tools to track, trend and report compliance metrics to ensure
Represents the company with regulatory authorities by facilitating regulatory inspections and third party audits, as required, in collaboration with appropriate functional areas, to ensure successful inspectional outcomes
Minimum of a Bachelor of Arts/ Bachelor of Science degree
Minimum of 5 years quality assurance experience in the pharmaceutical industry
Minimum of 4 years project management experience, preferably in a multicultural, global
Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate
Strong planning and organizational skills and experience managing multiple priorities

Quality Systems Manager Resume Examples & Samples

Develops, maintains and execute the site wide strategy for Deviation Management Excellence, including Root Cause Analysis, CAPA, and Technical Writing programs
Provides overall leadership in the management of critical (level I) investigation including establishment of investigation team, remedial actions, customer notifications and as appropriate establishment and support for restart activities
Investigates and reports on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems
Provides remediation solutions to manufacturing sites on critical quality issues, crisis management, response to regulatory deficiency letters and other topics as required
Provides the right level of follow up and scheduling to ensure investigations are completed in a timely manner consistent with the type and criticality of the event
Works with process experts and production personnel to fully understand and provide guidance on appropriate and complete corrective actions to assure repeat deviations do not occur. provides technical expertise and recommends improvements
Writes Impact Assessments and Investigation Reports, works within TrackWise
Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems
Informs Management in a concise and complete manner on the progress of on-going investigations, and participates in meetings of the Deviation Review Board, providing status reports and updates on root cause assessments and CAPAs
Possesses good technical writing and advanced critical thinking skills (to be enhanced by Catalent Certification program)
Develops, implements, manages and tracks effectiveness of corrective action plans for exceptions, and assures all exception documentation adequately address root cause, corrective & preventive actions and product impact
Aid in the continuous improvement initiatives of local site systems and global strategic projects for measureable deliverables
Champion the Deviation, Complaint and CAPA management review board
Responsible for monitoring and measuring and reporting deviation and CAPA performance and making recommendations for continuous improvement
Responsible for tracking, trending and reporting metrics
Responsible for the execution and tracking of change controls
Developing a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement
Ensure Quality systems are compliant with corporate and site procedures as well as industry standards including
Regularly reviewing and evaluating new regulatory information
Reviewing and evaluating new or revised corporate policies for compliance
Evaluating all audit inputs systemically as potential CI inputs
Effectively communicate Quality vision and expectations across site, including periodic site-wide GMP training in addition to focused trainings
Function as a strong Quality liaison to other functional department, providing meaningful quality support and ensuring productive cross-functional communication
Oversee training qualification programs for Pharmaceutical Technicians, QA Associates and Product Quality Specialists
Drive systemic process changes as a result of Deviations/Complaints and other quality trends
A Bachelor’s degree is required
Bachelor of Science in pharmaceutical applicable field; examples may include Science, Biology, Chemistry, or Engineering is preferred
Experience in quality and/or regulatory in the Pharmaceutical industry, or experience in a regulated industry with demonstrated understanding of manufacturing, regulatory and compliance is required
Five (5) years of experience in quality and/or regulatory in the Pharmaceutical industry, OR seven (7) years of experience in regulated industry with demonstrated understanding of laboratory, manufacturing, regulatory and compliance is preferred
Knowledge and experience in cGMP and FDA regulations is preferred
Knowledge of Trackwise, ComplianceWire and Documentum software is preferred
Demonstrated experience in successfully influencing others outside the incumbent’s department will be required
Exemplary organizational skills for self and team management
Ability to effectively present information and respond to questions from groups of managers, customers, and regulatory agencies
Exemplary project management and organizational skills
Ability to write reports, business correspondence, and standard operating procedures
Ability to multitask with high efficiency
Ability to work well under pressure and maintain efficiency
Customer focused and performance driven
Setting up office, desk and workstation for minimal ergonomic risk factors as deemed necessary
Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position

Quality Systems Manager Resume Examples & Samples

Directs the development and improvement of a laboratory-wide quality system and manages system implementation with technical and non-technical departments
Leads the establishment and improvement of an integrated laboratory quality system
Ensures compliance with regulatory and accreditation agencies' requirements
Identifies opportunities and implements processes and procedures to reduce laboratory risks
Designs or assists in process development and improvement throughout the laboratory system
Leads or facilitates continuous quality improvement projects and quality review processes
Manages quality improvement projects, costs, or standardization
Collaborates in developing quality strategies with the laboratory management team
Manages and maintains all appropriate regulatory licenses and certificates for all laboratory testing, both in the laboratory and in non laboratory areas
Ensures compliance for all POCT testing, manages the activities and performance of the POCT Coordinator of the laboratory
Ensures required regulatory, quality, safety and compliance training and education for all laboratory employees and non laboratory employees performing laboratory testing
Ensures laboratory quality and adherence to regulatory requirements through internal audits and tracers
Extensive (usually five (5) years) experience in an acute care hospital clinical laboratory required including demonstrated ability to utilize principles and practices of quality improvement/system
Bachelor's degree in clinical laboratory science or related field
Valid current California Clinical Laboratory Scientist
Other skills/experience should include demonstrable knowledge of statistical tools of quality, techniques of problem solving and improving work process, making presentations, and computer proficiency
Knowledge of federal, state, local, and accreditation agency regulations. Must be able to work in a Labor/Management Partnership environment
Master’s Degree or other certification in Quality Management, Lean, Project Management and/or Clinical Laboratory Management or related field preferred
Experience qualifying, maintaining and/or calibrating equipment strongly preferred
Experience with SharePoint, project management software and maintenance and development of electronic databases preferred

Quality Systems Manager Resume Examples & Samples

Excellent communication skills, both oral and written are required
Strong organization and multitasking skills
Ability to prioritize and meet deadlines for multiple projects
Bacheleor’s degree in Engineering or a related technical discipline
Experience in a Distribution Environment
Quality Certification (e.g., ASQ CQE, CRE, CQA)
In-depth knowledge of the following: AATB, CMDCAS, PAL, ISO13485, ISO 4971, MDD 93/42 EEC, and CFR 21 Part 820
Travel less than 10%
Must be able to travel independently to various Medtronic buildings/sites
The employee must occasionally lift and/or move up to 15 pounds

Quality Systems Manager Resume Examples & Samples

Ensures compliance with all the requirements of an AS9100 quality system
Establishes quality performance and process goals
Follows corporate guidelines on determination and reporting of group measurements
Communicates with other managers to coordinate quality related activities
Host both internal corporate and external registrar AS9100 audits
Guides and participates in all internal auditing activities including auditor training
Monitors technical work and assists in the identification and resolution of any technical problems that might affect product quality
Maintain the site quality manual in conjunction with corporate requirements
Maintains corporate data bases for corrective and preventive actions, customer returns, “read across” audit & escape findings, and supplier score cards
Effectively interacts with Production and Engineering teams to maintain customer product conformance
Writes technical procedures and creates technical forms
Reviews and ensures implementation of all customer and corporate specifications and product criteria
Oversees inspection operations to ensure product conformance
Works directly with customers to support product requirements
Works directly with suppliers to ensure compliance of supplied materials and products
Reviews supplier purchase orders to ensure product and corporate requirements are being met
Works with purchasing staff to establish quality requirements for external suppliers
Active participation in customer contract reviews to ensure product compliance
Makes final determinations or dispositions related to non-conforming material with inspection staff
Monitors calibration activities and tracks compliance
Oversee all Corrective and Preventive Action activities with a focus on continuous improvement
Responsible for all facility quality training including New Hire Quality Orientation
Participates and oversees material testing activities
Interface with and conformance to Corporate Quality and ABS systems
Extremely detailed-oriented
Able to work hands-on when required to solve problems
Ability to develop, review, and maintain metrics
Strong work ethics and positive team player
Recognize and prioritize quality issues
Ability to manage time
Bachelor’s Degree from an accredited university
At least 2 years of experience with quality systems
This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as a US Citizen, U.S. Permanent Resident (ie. Green Card Holder, Political Asylee, or Refugee

Senior Quality Systems Manager Resume Examples & Samples

7+ years' work experience including 5+ or more years of relevant quality system experience in a medical device manufacturer
Previous experience with ISO/CE certification process
Previous experience with US and international medical device regulations
Effective interaction with personnel at diverse positions within and outside of the organization
Previous experience the management of FDA Inspections
Previous experience the management complex Quality System implementation projects
Previous experience in Supply Chain or Distribution Quality
Professional Quality Certification (e.g., ASQ CQE, CRE, or CQA)
In-depth knowledge of the following: AATB, CMDCAS, PAL, ISO 13485, ISO 14971, MOD 93/42 EEC, and CFR 21 Part 820
Must be able to travel independently to various Medtronic buildings/sites including internationally
The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls
The employee is occasionally required to reach with hands and arms
Specific vision abilities required by this job involve normal vision
Travel up to 25%

Quality Systems Manager Resume Examples & Samples

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Advocate a team concept. Proven ability to motivate personnel in order to balance staffing strength with profitability and growth
High energy level, capable to handle multifaceted projects in conjunction with normal activities
Well-developed interpersonal skills; ability to get along with diverse personalities
BS/MS in Science or Engineering
Six Sigma Black Belt and/or Lean Manufacturing certification preferred
Experience: 8+ years of experience in a leadership role in QA/manufacturing environment in a medical device company or other regulated, critical end-use product industry. Mechanical assembly and chemical manufacturing processes
Demonstrated analytical and data based decision making skills, statistical sampling and analysis and proficiency with Minitab statistical software. CQA/CQE
Knowledge of medical device regulations, a plus
Strong oral and written communication, computer (Word, Excel and Powerpoint)

Quality Systems Manager Resume Examples & Samples

Knowledge of New Product Development processes
Knowledge of engineering practices, test protocols, and documentation
Skilled in problem solving and process improvement
Ability to perform component engineering design and changes
Ability to operate light machine tools and laboratory instruments
Ability to interpret displayed results on laboratory instruments
Minimum ten (10) years of experience in design, manufacturing, or quality engineering position (medical device experience preferred)

Quality Systems Manager Resume Examples & Samples

At least 8 years of quality experience in medical device or similar environment
Project management experience in global environment
Knowledge of ISO13485 and its implementation is an advantage
Project Management Skill and Lean Six Sigma Skill is required
Operational Excellence experience is required

Quality Systems Manager Resume Examples & Samples

A BS or BA in related technical or science field
Expertise and Certified to ISO 9001 as a Lead Auditor is a must (updated certification to the 2015 Revision is preferable)
Experience as Quality Systems Manager with 5 Years minimum
Good written and verbal communication skills in both Spanish and English
MS Office Software, Minitab, Data Base Management and Basic Statistical Technics Expertise, Troubleshooting Methods, e.g. 8D’s
Experience Desirable on PED normativity for European Union
Experience Desirable on ASME Code Section VIII for Pressurized Vessels Design and Fabrication
Desirable (but not essential) qualifications: Member of American Society for Quality (ASQ), Certified Quality Engineer, Quality Manager, or Reliability Engineer
MBA desirable, with focus on Quality Administration
Six Sigma Green Belt Certification (minimum)

Quality Systems Manager Resume Examples & Samples

Develop, manage, and continually improve Quality Assurance programs, policies, intranet applications and databases
Manage Quality programs, systems,, PF internal & external audit programs, evaluations, assessment programs and databases. Provide Training and and guidance on Quality systems and programs
Develop QA tools for continual improvement and assessment, lean sigma tools
Standardize, deploy, and improve QA data structures and reporting tools/metrics across Pepperidge Farm
Manage cross-functional matrix relationships with R&D, Supply Chain, and influence senior management to ensure alignment of Policies, systems, data, annual objectives, and project plans, act as project leader
Provide leadership to Product development/technology/business development, and quality staff members within HQ organization and at the Pepperidge Farm manufacturing plants. Work with Pepperidge Farm supply chain leadership to provide guidance, support in the development of quality and supply chain staff
Provide technical expertise and leadership in quality, food safety, and risk assessment programs/policies/events
Expert abilities and decision quality in Food Safety, Regulatory, Process Improvement, Quality Systems and their application within food processing
Knowledge of Global& Pepperidge Farm Quality Standards, and Quality Policies, with skills and ability to execute against requirements
Able to partner with supply chain to effectively manage Supply Base to Expectations and Requirements Manual, Specifications, Non-Conformance resolution, Sanitation, improvement in KPI's, External audit targets and resolution of audit action plans
Strong partnering and relationship development with external technical organizations and associations
Ensures group is technically capable of handling non-routine quality system issues and that issues are thoroughly investigated, documented, and resolved
Record of leadership and demonstrated success in collaborative development, documentation, planning, and implementation and continuous improvement of quality systems
Ability to manage multiple responsibilities with urgency via strong project/event management skills
Strong strategic vision/ability; Skilled at aligning business plans with strategic objectives
Strong partnering and and relationship development with external technical organizations and associations
Capable of successfully engaging other business unit quality in the development and standardization of programs, policies, templates, standards, procedures
Knowledge of IT technologies and their application to Quality Assurance objectives/programs

Senior Quality Systems Manager Resume Examples & Samples

Bachelor’s Degree in engineering discipline
7+ years of quality or manufacturing experience
5+ years management experience
7+ years experience in GMP medical device environment
Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003
Internal and external auditing
Corrective Action
Process Improvement Methodology
PC skills, work processing, spreadsheets, project management, etc
Effective verbal and written communication, analytical, influencing and interpersonal skills
Must be able to communicate at all levels and across company lines
Advanced degree in business or engineering
3+ years Quality Assurance experience in a QSR (GMP), disposable medical device environment
TQM
Presentation and training expertise

Quality Systems Manager Resume Examples & Samples

Responsible for the safety of all individuals within the quality control group, including disposal of the pertinent hazardous waste material
Keep quality control laboratory employees informed of company / department plans, policies and procedures
Responsible for developing fiscal expense budgets for the Quality Control/Quality Assurance responsibilities. Incumbent must possess the skills and knowledge in accounting to develop and maintain an effective budget. Responsible for cost control and associated production expenses within assigned area
Presents a monthly report of the quality control/assurance performance criteria and comments on significant deviations. Incumbent must have knowledge of spreadsheet software and an above average understanding of personal computers and the SAP system
Responsible for creating an environment of continuous improvement within the assigned area and developing awareness for product and production quality. Good communication skills (verbal and written) and an understanding of the process units are required
Support the development of and assistance to lab technicians in troubleshooting equipment, test methods and any other functions as requested by staff members or as necessary, also ensure prompt notification of results. Assist maintenance personnel to insure the safe and proper upkeep of laboratory equipment and facilities
Ensure lab procedures are up-to-date, complete and properly followed, report/coordinate any modifications, changes, additions or deletions with the DCUSA appropriate manager and corporate technical department (DCDK)
Manage DUSM efforts for HAACP, ISO, AIB, Kosher, Grade A, GMP, Allergens, kosher for Passover) certifications and coordinate audits to ensure maintenance of above certifications
Ensure maintenance of all specifications for all DUSM materials and packaging
Serve on corrective action boards as the quality control representative, promote the use of the board as a decision making group for all non-conforming materials. Incumbent to use their knowledge of the applicable specifications for raw materials, packaging raw materials and intermediates, including disposition of these materials
Ensure coordination of all outside laboratory testing needs and lab evaluation of quality on customer complaints, product studies, product history, competitor samples, etc
Oversee distribution inspections and provide updates of inspection procedures and standards
Compliance with applicable company policies, including maintaining a drug free work place is required
Compliance with all Company policies is required
Other functions as required and assigned by management
In conjunction with IS, responsible for application/data ownership of computer systems, as designated. This includes existing and/or new implementation(s) of applications, user application training, and user authority in the application. Also responsible for accuracy and timeliness of data entry, data processing of transactions and related functions (individually or performed by staff)
Responsible for adherence to all quality systems including, ISO and Food Safety, with an understanding of DuPont Nutrition & Health Cultor' Quality Policy and procedures. Responsible that these policies and procedures are implemented throughout the organization and all related activities under the position's jurisdiction
Responsible to participate in the Quality Council, which reviews goals for advancement of DuPont Nutrition & Health Cultor's Quality Systems
Maintain well-trained and productive Quality Control staff, including technician certification
Maintain a safe working environment for all individuals within the quality control facilities
Maintain the smooth operation of the DUSM quality systems, following established GMP’s, HACCP procedures and the ISO Quality System
Ensure compliance with the FDAregulations and applicable test methods for Grade A, Allergens, Kosher, and Kosher for Passover. RSPO (Round table on Sustainable Palm Oil) supply chain certification system
Ensure up-to-date procedures, documentation and statistical analyses that are consistently followed with instructional manuals and procedural guides
Timely reporting of discrepancies to the operations management
Ensure lot traceability of manufactured products
Timely and cost efficient quality control laboratory services regulated within the approved fiscal guidelines
Promote a focus of continuous improvement and customer satisfaction in the quality control operations
Positive customer relations and timely meeting of quality control needs, including accurate and complete maintenance of customer information
Support G&S, Pectin and the product Services groups through participation in formula/product reviews, changes and new product development opportunities
Bachelor’s degree required: Chemistry or Biology degree preferred
Minimum of 5 years in the food industry required
Minimum of 5 years in supervision/management with increasing responsibilities is required
HACCP; GMP and ISO Quality Systems experience required
Ability to work independently with a mechanical aptitude to perform trouble shooting of equipment is essential
Experience in supervising the activities of the QC Supervisor
Must possess good organizational skills to accomplish all responsibilities
Must possess strong management communication and interpersonal skills
Knowledgeable about the analyses and tests performed in the Quality Control Laboratory

Quality Systems Manager Resume Examples & Samples

Manage the NCR and CAPA processes and systems for the site
Represent the site on the world wide NCR and CAPA teams
Work effectively with other NCR / CAPA site leaders to ensure consistent systems and processes at Ethicon plants
Drive the improvement and development of NCR and CAPA system for the facility
Responsible for the overall management and effectiveness of the NCR and CAPA processes, including leading and facilitating of relevant data review forums
Provide education and mentoring as needed regarding NCR and CAPA (beginners and continuous education)
Develop and implement measures to monitor the effectiveness of the NCR and CAPA systems
Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator
Serves as the initial point of contact for Product Complaints / Product Quality issues and ensures Risk Assessment is timely and adequately addressed
Support site risk management process
Oversees the complaint product evaluations activities for the site, and maintains track and trending of product performance / results of product evaluations for escalation to CAPA
Participates as a key member in both external and internal audits and is responsible for the local NCR and CAPA processes and directed inspections
Actively participates in Management Review
Facilitates and leads the plant CAPA Review Board
Report NCR and CAPA results / metrics to the Plant QA Manager and Management staff as applicable and makes recommendations for improvement
Partner with management to develop and implement meaningful trending of NCR's and CAPA performance
Ensure major non-conformances, trends, and near misses are escalated to management and prioritized commensurate with risk
Lead major issues, when appropriate
Responsible for ongoing CAPA process and CAPA system training (beginners and continuing education for experienced associates.)
Opens new CAPA's and assigns the team leader in the computer system
Ensure the appropriate resources are assigned and held accountable for nonconformance resolution and CAPA effectively
Work with team leaders to establish and track an effectively measure for each CAPA
Manage the NCR/CAPA system, to include monitoring and ensuring Due Date Adherence
Leverage Process Excellence tools to effectively implement CAPA using a DMAIC approach
Responsible to mentor both technical and non-technical resources in investigation, troubleshooting, escalation, and resolution of product and process quality issues, NCR and CAPA
Works with CAPA team leaders to charter new CAPA's
Provides guidance to team leaders and approvers and reviews all CAPA's to ensure documentation is complete before CAPA closure
Communicate with NCR / CAPA leaders globally to ensure alignment, resolve problems, and share best practices
Supports the continuous improvement of the CAPA process and computer system
Partner with IM and the data warehouse team to drive improvements in business intelligence to facilitate effective tracking and trending
Perform other work-related duties, as assigned by site management
Minimum 5 years’ experience in Operations, Engineering and/or Quality Assurance is required
Background in Medical Device Industry, preferred
Experience leading CAPAs is an asset
Knowledge of regulatory requirements (ISO, QSR, etc.), preferred
Experience with external auditing bodies, preferred
Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, preferred,
Demonstrated project management skills with strong results orientation, required
Strong communication, influencing and presentation skills, required
Bilingual, fluent in English and Spanish
Physical Demands: Normal office environment, mental efforts
Work Environment: Frequent travel, Flexible to work on different shifts
Contacts: Frequent contact with Ethicon facilities and Executive Management required

Program Quality Systems Manager Resume Examples & Samples

Develop and implement the program-level quality management framework for the entire program; includes design quality management, construction quality management, and adherence to all appropriate laws, regulations, and standards
Oversee the development of quality management systems to include the comprehensive quality management plan as an essential component of the program management plan
Evaluate and ensure successful administration of designer and construction contractor quality management programs to include the development and rigorous execution of project-specific quality management plans
Conduct audits of designers and construction contractors to check compliance
Establish a non-conformance management system to aid in the identification, tracking, and resolution of all deficiencies
Serve as a key leader within the program and ensure that all program standards are maintained and enforced
Develop briefings and presentations as necessary for client, stakeholder, and AECOM senior management
Train subordinate leaders in quality and quality management practices and protocols
Conduct audits of AECOM internal systems and ensure compliance with all AECOM policies, protocols, and the AECOM Project Delivery System
Background in project/program management
Able to work as a senior leader of a dynamic and fast moving team
Experience in managing a small team
Ability to systematically analyze complex problems, draw relevant conclusions and implement appropriate solutions
Excellent negotiating and persuasive skills, both in one-on-one and group situation

Quality Systems Manager Resume Examples & Samples

Recruitment of the quality team in conjunction with HR business partner assistance
Development of detailed product and site transition plans that will ensure robust process definition and right first time product quality
Manages the planning and execution of last article / first article activity for all parts being transitioned
Act as the expert on various customer and industry quality system models such as ISO9000, AS9100 and D1-9000. Recent experience with the revision C version of AS9100 is preferred
Adherence to the GKN Life Cycle Gate management process including the assessment of risks and identification of associated mitigations
Ensure that technical expertise is provided to team members, suppliers and third parties ensuring compliance with contractual, company and regulatory requirements
Ensures that export compliance, data protection and other relevant regulations and legislation for the region are followed
2+ years of experience leading quality teams/organizations

Quality Systems Manager Resume Examples & Samples

Serving as a backup Management Representative for audits/inspections
Maintaining communication with certification bodies
Staying abreast of changes to QMS standards, ISO13485 and 21 CFR parts 820, 4, 11, 210& 211
Providing direction and support to personnel regarding new/revised standards and regulations
Facilitating the development and implementation of QMS improvements
Assisting personnel with QMS issues
Communicating QMS issues to management
Supporting compliance to the Safety and Environmental policies and programs
Aiding in setting priorities and participating in Lean Six Sigma initiatives and projects

Quality Systems Manager Resume Examples & Samples

Lead the plant Quality staff to ensure compliance to the overall Quality Management System and to drive Continuous Improvement
Provide coaching, mentoring and leadership to the plant Quality staff
Lead and own the plant Management Review process
Ensure and drive compliance with the domestic regulatory and international standards and requirements
Lead the site’s quality improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/process quality dashboard
Manage the complaint handling processes to ensure customer responsiveness and product and process improvements
Lead the quality plan development and execution for manufacturing site New Product Development ensuring successful product design transfer
Lead qualification and monitoring tasks for manufacturing site key suppliers to ensure effective supplier performance in the manufacturing process
The position requires a level of authority to conduct and direct required activities. Examples of this are: Quality planning, complaint management, production and process controls, CAPA management, supplier management and new product design transfer
This position requires 5 – 10 years experience in a Manufacturing, Engineering or Quality/Continuous Improvement environment. Experience with supervision of technical and regulatory professionals is highly desirable
This is a middle management position involving the supervision of a small team, composed of either technical or professional employees
Proven leadership ability to manage a team, make decisions and deliver results
Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis
Working knowledge of IS0 9000 and FDA GMPs
Ability to set goals and meet project deadlines
Effective communication skills, both oral and written are required
Ability to establish and maintain an effective working relationship with subordinates, peers, and all levels of management
Experience with Class III or significant Class II devices

Quality Systems Manager Resume Examples & Samples

Must have expert GMP Compliance, Product Quality, and in-depth Risk Management knowledge
Ability to effectively prepare communications to identify potential problems to management and the group with clarity and a high level of accuracy
Provide guidance to other employees in the interpretation of compliance and technical/scientific issues across a majority of the job function. Develop employees and coach them to bridge knowledge gaps
Strong authorship and be able to critically review reports while effectively providing input and expressing Quality Risk management principles
Action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity
B.A. in a related field; 7+ years experience in the pharmaceutical industry with >3 years experience in investigational drug development, GMP manufacturing packaging and/or labeling operations preferred
Strong background in cGMP requirements
Demonstrated skills in project management and handling multiple projects simultaneously
Familiarity with regulatory requirements with respect to investigational drug products
In depth knowledge of clinical trial documentation and retention requirements
Demonstrated teamwork and collaboration skills
Ability to lead, motivate, and develop employees

Corp Quality Systems Manager Resume Examples & Samples

Develop and lead work plans and initiatives to achieve and sustain the ISO compliance of the quality management system across the organization
Engage with the plants and Corporate Value Stream teams addressing quality management system gaps and corrective actions in order to develop strategic improvement plans
Lead the development, maintenance and deployment of the Quality Manual, corporate SOP’s, and associated forms and records
Manage the internal quality audit program to ensure the company is compliant to ISO standards, corporate SOP’s, process specs and best practices in order to achieve sustainable World Class performance
Develop scorecards and reports to measure the effectiveness of Quality System
Aid in the development, maintenance and assessment of the American Woodmark Operating System
Organizational Development: Develop functional core competency training and training roadmaps
Serve as a team leader or team member on cross-functional teams, as needed, in order to help the company continuously improve
TEAMWORK: Support efforts by all members the American Woodmark team to continuously improve company performance
Bachelor Degree required, Advanced Degree preferred
Minimum experience of 7 years in a manufacturing field with some supervisory experience in a multi-site organization is required
Experience developing, deploying and managing a recognized quality system, such as ISO or TS, is required; Knowledge of World Class Operational Excellence models, such as Baldrige or Shingo, are preferred
Knowledge of Lean and Six Sigma methodologies and professional certification such as ASQ CQA or RABQSA Lead Auditor preferred
Ability to work in a team environment as well as independently is required
Ability to work internally and externally at all levels in domestic and international is required
Track record of successful project management and team experience are required
Personal computer skills in a networked environment, Microsoft products (Word, Excel, PowerPoint, Outlook, Sharepoint) are required
Management style and duties must be consistent with and support AWC’s CITE Principles, Supporting Values, Mission and 2019 Vision

Quality Systems Manager Resume Examples & Samples

Lead team to facilitate, and support Management Review, Internal Audits, Complaint Management, CAPA Management, Quality Metrics, Nonconformance Management, Field Actions, Software Validation, Training, Maintaining Certifications and Registrations. Maintain current knowledge of applicable cGMP/QSR, ISO, and other related regulations
Manage department budget in accordance with Annual Operating Plan
Write and maintain Quality Procedures, to include Work Instructions and SOP updates. Ensure the Quality functional requirements are compliant with corporate procedures as well as industry standards and regulations
Implement, maintain, and/or improve the quality system to meet or exceed regulatory and ISO compliance
Responsible for specific global processes as the Global Process Owner. Responsible for administering process improvement and evolution for the global process
Other project work as assigned
Solid oral and written communication skills
Planning and organization. Ability to manage multiple projects/responsibilities at one time
Experience in creating and implementing a quality system in a Medical Device Company preferred
Leadership, Collaboration
Driving Alignment, Empowerment, Accountability
Technical or Life Science degree (BS) or equivalent medical device experience
Minimum 2 years management/supervision experience
Minimum 5 years working in Medical Device or Orthopedic company preferred
Minimum 5 years in a Quality Engineering, Quality Systems, or Internal Auditing role, or combination
Combination of education and experience may be acceptable

Quality Systems Manager Resume Examples & Samples

Oversees and manages Quality Systems; develops detailed action plans, defines resource requirements, performance measurements, and aligns staff with the overall quality strategic objectives
Responsible for planning, implementing, and reviewing the strategic quality goals
Facilitates inspections and audits with regulatory and third-party agencies and follow-up responses to findings
Facilitates and manages the internal and external proficiency testing program. Responsible for ordering external PTs and creating schedule for internal PTs
Responsible for the complaints management program including trending and communication of issues to the complaints management team
Manage a team of 1-5 direct reports on the Quality Assurance team under the following job profiles
Quality Control Technician,
Quality Systems Specialist,
Sr. Quality Systems Specialist,
Quality Systems Coordinator
Bachelor of Science degree in a life science related field required
Quality-related certification (i.e. ASQ, CPHQ, etc.)
Proficient with MS office programs (Word, Excel, Powerpoint, etc.)
Strong analytical, written/verbal communication, interpersonal, and relationship building skills
Knowledge of applicable federal and state laws and regulations
Minimum of 5 years experience in a clinical lab environment or equivalent

N Quality Systems Manager Resume Examples & Samples

Direct development, initiation and monitor quality manufacturing techniques to track financial results and report on quantifiable goals and objectives
Develop, implement and manage strategic / tactical programs to increase quality and reduce cost
Integrate existing quality systems between the LR/CF product lines and elevate to a benchmark status
Coordinate and review customer complaints for compliance with 8D process and timely completion. Monitor rates of receipt, analysis and completion
Ensure alignment with field service team to measure and reduce COPQ
Manage contracts and ensure all QA requirements and specifications are met or exceeded
Interface with suppliers on specific contracts to ensure their adherence to QA requirements as they pertain the supplier scorecard
Provide oversight to establish, initiate and monitor any internal control policies relating to quality performance initiatives. Develop and communicate quality performance data to all relevant plant personnel for corrective action
Lead the development of all procedures required for ISO 9001 certification and re-certification. Maintain all quality performance records and documents. Coordinate ISO visits with necessary staff and manage any corrective actions that occur as a result of the ISO audits
Manage the creation and implementation of the technical training programs for SPC, ISO 9001 procedures and problem solving. Ensure QA Engineers / Techs are conversant with all programs and can adequately train production or other Engineering staff to processes
Apply performance, test and inspection data to investigate causes for product nonconformance. Identify issues and serve in the lead role to facilitate problem resolution. Develop internal / external inspection, gage calibration functions and the supplier quality program
Define performance metrics to measure, compare or evaluate quality factors, such as cost of quality, on time performance, first pass yield, scrap, rework and warranty & customer complaints to ensure compliance maintains or exceeds metric standards
Participate in VOC supplier meetings to share performance results, obtain supplier input, collaboratively analyze Nash & supplier feedback, develop shared solutions, implement new or improved processes and discuss Quality changes
Effective management and leadership of Quality Team
10+ years’ experience, in a N. American operating environment, leading quality management and quality assurance programs preferably for large rotating equipment products or highly engineered industrial products/systems
Bachelor’s Degree (or international equivalent) in Quality or related field, i.e., Mechanical, Industrial or Manufacturing Engineering,
Proficient in computer software programs for business, such as Microsoft Office Suite & Lotus Notes, and relevant supply chain software, such as SAP and ERP software
Demonstrated ability to effectively interface with all levels of the organization, as well as customers, government officials and vendors
Demonstrated effective analytical and root cause problem resolution skills
Demonstrated ability to coordinate cross-functional teams and effectively resolve process issues
Demonstrated experience applying business and management principles involved in strategic planning, resource allocation & coordination [material, money & people], leadership techniques and production methods, end product knowledge, product & service competitors
Demonstrated ability to leverage principles and processes that provide quality customer services, including customer needs assessment, meeting quality service standards and customer satisfaction evaluations
Real world, practical application of engineering science & technology, which includes applying principles, techniques, procedures and equipment to the design & production of goods & services

Quality Systems Manager Resume Examples & Samples

Demonstrated use of GSK Values
Patient Focus
Act with Integrity
Transparency
Respect for People
Ensure Halal Assurance System is operating in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable products/markets
Ensuring that process needed for the QMS are established, implemented and maintained
Reporting to Senior Management on the performance of the Quality Management System and any need for improvement
Ensuring the promotion of awareness of regulatory and customer requirements throughout the site
Liaising with relevant Regulatory Bodies e.g. Notified Body and Competent Authority
Perform duties in a compliant manner and behave in accordance with site SOP’s, GSK EHS standards and guidelines and relevant legal requirements
Read and understand Standard Operation Procedures applicable to role
Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor
Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards
Be aware of the impact of your job activities on EHS issues
Ensure all engineering changes made have safety considerations and best practices as core attributes
Ensure basis of safety files are available and up to date for processes
Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to
Maintain GMP standards where appropriate to your role
Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
Management Policies relevant to your job role
Attend training and complete assessments as required
Ensure Quality and GMP are at the forefront of changes proposed
Ensure Inspection Readiness Every day
Identify and co-ordinate the activities and resources to prepare for the
GMP and Regulatory Compliance, Quality teams performance, Quality Systems departments on both sites, Suppliers, Health Product Regulatory Authority (HPRA) and SGS
Recruit suitable candidates as required
Effectively manage and develop talent of employees
3 – 5 years experience in a pharmaceutical / healthcare industry in a Quality management capacity
Understanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinals for required markets
Understanding of Japanese Quality Requirements and Working Relations
Ability to provide key input into Quality management decisions as management team member
Ability to effectively lead, develop and motivate the QS team
Understanding of and ability to implement GPS initiatives
Ability to communicate with a wide variety of people at all levels both within the sites and GSK and externally through appropriate skills: - Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening
Demonstrated ability to problem solve
Demonstrated ability to effectively plan work and to manage projects
Third level science-based degree (preferably post graduate)
Understanding of appropriate Directives, Standards, Quality Management Systems related to the manufacture of Medical Device and Medicinal for required markets
Ability to provide key input into management team decisions

Quality Systems Manager Resume Examples & Samples

Responsible for the consistent and correct execution of QS global procedures within the site to ensure the quality and compliance of processes and records for Change Control, Records Management, CAPA, NC, Customer Complaints Investigations, QPR and QSMR and Filed Action Investigations
Develops competency of resources within the site that execute CAPA, NC, Customer Complaints, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes
In partnership with the site Quality leaders, oversees the timely and compliant execution of site NCs, CAPAs, Customer Complaints, QPR and QSMR, by championing collaboration across functions and sites and developing action plans, as required, in order to improve or sustain associated metrics at target levels
In partnership with the site Quality leaders, oversees the Product Escalation process for non-conformances, complaints or other issues potentially impacting product in the field. Reviews related investigations and corrective action plans to avoid reoccurrence of the nonconformity. Ensures timely closure of escalations
Identifies needs to meet and improve system performance of NC, CAPA, Customer Complaints, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner
Collaborates with The Regional Quality System Leader in the deployment of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level
Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for Change Control, Records Management, NC, CAPA, Customer Complaints, QPR and QSMR during audits; managing the investigation, response, and remediation of site-specific QS audit observations
Oversees the execution of Document Control across the site. Partners with Global QS in the implementation of system improvements and training deployment, as required
Other Quality Systems related tasks, responsibilities, and projects as assigned
Universal Leadership Competencies: (Connect) Cultivate external relationships and partnerships, Forge internal collaboration across all levels of the enterprise, (Shape) Challenge the status-quo; lead and adapt to change, take and manage risks, (Lead) take ownership for talent acquisition, performance and development of self and others, Engage in transparent and constructive conversations
Differentiating Competencies: (Connect) Be insight-driven to uncover unmet needs, (Shape) Translate insights into viable products and solutions that create value, (Deliver) Empower people to act with speed, agility and accountability
Specific Technical Skills Required: Project Management; Technical Writing; Quality System Integration, Quality Auditing, and Risk Management knowledge. Ability to apply principles of logical or scientific thinking, root cause and statistical analysis. Presentation Skills. Working experience of applicable software (Microsoft Word, Excel, Power Point, Microsoft Project)
At a minimum, BS degree in Engineering / Scientific or associated relevant technical / Quality discipline is required; Engineering degree preferred
Five (5) years related experience in Medical Device or Pharmaceutical, or Aerospace environment, or equivalent combination of education and experience is required
Solid knowledge of ISO and QSR regulations required; experience with front and back room leadership in third party inspections required
Experience with root cause investigation and change management is required
Direct supervision experience is required
A Certification in process excellence preferred
This position will be based in Elmira, NY and requires up to 10% travel4724170314

Quality Systems Manager Resume Examples & Samples

Manager for the Quality System, Supplier Quality, Incoming Inspection and Calibration teams at SenDx
Project lead on cross functional process improvement projects
Help establish quality system at a new manufacturing site
Collaborate with R&D as Design Control Specialist to deliver the right documents in the right quality in the development process to successfully register the products globally
Continuously improve and develop processes for Design Control, Risk Management, Usability Engineering and Design for reliability
Make quality related decisions and sign off on quality documents on behalf of the QA management
Specialist in verification and validation of products and processes
Support manufacturing value streams in quality related matters when needed
Ensure the processes are in compliance with both relevant regulatory and internal requirements, and are implemented and maintained so the necessary governmental approvals are maintained
Is up-to-date with standards, regulatory requirements and directives applicable for SenDx products
Ensure the QA system is kept lean and updated and that the organization complies to the system
Work with Radiometer Medical to develop and implement global procedures
Benchmark with other Danaher companies to explore and align best practices
Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities
5-7 years in the medical device, pharma, or dental industries; experience from managing teams

Senior Corporate Quality Systems Manager Resume Examples & Samples

Manage, maintain and enforce internal audit control policies across the enterprise
Drives R&D process review sessions across for all VZT brands (VZT, NWF, Telogis and Fleetmatics)
Analyze current state and work with functional leaders and define business processes to meet defined business objectives
Ensure that all IT processes and sub-processes are documented so that it enables maturity of operations practices
Review and analyze IT process and sub-process documents and Approve or Reject them based on their adherence to documented policies, and assist in determining the corrective actions required to align them with industry standards
Participate in determining long term planning and contribute to overall business strategy
Document and report status of audit plans to appropriate technical and business teams to ensure that proper documentation and audit trails exist for all activities performed related to the audit process
Assure that each process documents is approved by the required approvers before implementation
Communicate high risk/high impact audit issues to the R&D leadership team as needed for their review and approval
Measure effective execution of customer contracts
Lead projects determined by the executive team to propose new solutions to business process problems based upon both quantitative and qualitative data within Corporate Quality
Lead and coordinate the agenda for quarterly audit meetings
Use Lean Six Sigma problem solving tools, including process mapping
Update, maintain and publish Audit Calendar; and organize and manage the process
Transform new designs to standardized work with assigned responsibilities
Identify needed metrics to drive and sustain business improvement
Create and deliver training presentations
Perform ISO 9001 and other ISO process audits to determine business effectiveness, and implement and maintains ISO 9001 compliance for R&D
Respond to quarterly and annual audit requested related to process documentation
Collect and report on trends/metrics to proactively identify areas for improvement
Capture, track and publish process efficacy using established Key Performance Indicators (KPIs) and Critical Success Factors (CSFs) through a measurement system that tracks adoption, utilization and proficiency of individual processes
Maintain and improve process effectiveness (quality), process efficiency (cost), process performance (throughput) and process vulnerability (security) through providing knowledge, expertise and training on the use of the process and tools
Collaborate with team members (especially Security Operations) to identify and operationalize IT processes and establish new KPIs as needed
7+ years' experience working with and improving processes within a standard ITSM framework such as ITIL and good knowledge of general IT concepts, e.g. applications, servers, network, database, etc
Strong analytical, organizational, and problem-solving skills
Excellent communication skills with the ability to communicate clearly and effectively
Strong customer service orientation with a focus on meeting and exceeding customer expectations
Ability to effectively manage client & staff relationships, promptly respond to queries, ensure promises are kept, and manage expectations
ISO 9001 Internal Auditor or equivalent
Six Sigma Green Belt or equivalent
Disciplined problem solving skills with excellent follow-through using DMAIC process
Advanced planning and organizational experience within fast-paced/dynamic business environments
BS/BA required – business or computer science discipline
Determined and committed to perform at highest quality and excellence
Laser-sharp focus on goal of on-time and zero-defect delivery
Highly energetic and strongly believes in on-going learning in order to optimally exploit his/her potential on the job
Constantly works towards being the best and to succeed at current assignment/project
Entrepreneurial mindset and successfully challenges existing paradigms
Has a strong vision and thinks expansively and outside the box to consistently generate and evaluate highly innovative ideas and solutions
Willing to take risks, anticipates the consequences of decisions and will generate plans to address them
Willing to go against the grain, has courage to take calculated risks and will have the ability to present his/her point of view in a positive and effective manner
Takes personal responsibility for ensuring customer satisfaction, takes customer perspective and will proactively work to address the customer’s current problem and future requirements
Ability to effectively leverage diverse resources. Works hard to foster positive relationships and will develop win-win solutions when conflicts arise. Builds relationships by making self highly approachable, seeks input from others and will actively listen to concerns and alternate points of view and makes others feel valued and supported
Team player – willing to take calculated risk
Legal and/or Regulatory experience
Familiar and comfortable working in a 24x7, high-availability service delivery environment
No particular bias towards specific technologies, vendors, or products
Effective at driving short-term results that are consistent with long-term goals
Skilled at operating in a matrix environment
ITIL Foundation Certification or higher

Quality Systems Manager Resume Examples & Samples

Role is the Guardian of Q&FS compliance and challenger of all functions across the site to drive Continuous Improvements in support of the Site’s Innovation & Renovation process, while fostering a cross functional quality, compliance and performance culture
Is responsible for the leadership and the development, implementation and management of all Site Q&FS programs and activities, including creating guidelines for testing novel products with Consumers in various venues
Provides technical expertise and support to ensure compliance to NQMS, FSSC 22000 / regulatory requirements, product quality (PrIME) attributes, and new food safety standards with proprietary raw materials, innovative processes and new routes to Market
Utilizes tools such as auditing, risk assessments/modeling, process evaluation, trend analysis to achieve Site and Global CT-PTD objectives, including providing expertise to Frozen & Chilled Factories in the Nestlé Group
Leadership to the markets and factories is a key activity – communicate the latest scientific and technological information for practical application in the factory
Reports to the Quality & Food Safety Group Manager
Minimum of a Bachelor of Science (B.S.) degree in Microbiology, Food Science or similar discipline. Masters preferred
Must be able to practically apply scientific knowledge to product quality and process safety
Minimum 5-7 years Quality Management experience, preferably in food manufacturing or consumer goods industry. Within this there must be 2-3 years of factory QA experience, preferably at a QA Manager level
Must have strong knowledge and understanding of food safety / HACCP, GMP’s, Allergen Controls, Sanitary design/controls, pest control, related food regulations, specifications, product release, analytical and microbiological lab methods and food technology processes
Facility utilities support (QMS, HACCP, sampling, data management, troubleshooting)
Competence in Quality & Food safety related systems & principles
Competence in Microbiology and Hygiene monitoring
Strong demonstrated verbal / written communications, influencing skills, analytical and problem solving skills. Must be detailed and results oriented
Statistical analysis & Focus Improvement (FI) experience is preferred
Nestlé NQMS, FSSC 22000, HACCP & FDA-PCQI training or similar Food Safety and Quality Systems training. Implementation experience on Food Safety and/or Quality programs is strongly preferred

Quality Systems Manager Resume Examples & Samples

Ensuring Metal Coaters is compliance with Quality Policies established by the Metal Coaters Management Review Committee
Analyzes KPI variables to diagnose chronic problems that result in poor quality, yield loss and field rejections of finished product. Provides corrective actions to eliminate chronic quality non-conformities or field rejections
Monitors technical, product and process developments and serves as a company technical representative to relevant trade association committees. Ensures that the facility management group is updated with regard to product development changes and technological advances
Plans and leads all plant-wide quality and yield improvement activities
Responsible for specification and evaluation of all incoming raw materials to Metal Coaters (i.e. Paint, Metal Substrate, Chemicals, Solvents)
Ensures the compliance of raw material suppliers to Metal Coaters Quality System requirements
Responsible for all of the Quality Assurance Systems (i.e. technical standards and test procedures) in place to produce and evaluate finished products
Ensures that all finished products meet or exceed customer requirements and that all non-compliant (HFI) material is diagnosed and handled properly
Responsible for ensuring departmental employees are trained and available to safely support the production department through testing, evaluation and processing of raw materials and finished products
Ensures all Metal Coaters employees are trained relative to their Quality Awareness responsibilities
Assists Sales with all aspects of customer technical service, including product development (R&D), product specification issues and development of new customers/opportunities
Responsible for the Customer Complaint Resolution process. Ensures timely resolution of customer complaints (claims)
Responsible for understanding and complying with the fundamental principles associated with the Quality and Environmental Managements systems in place at Metal Coaters
Responsible for communicating daily with all levels of employees in order to assist in resolving problems and achieving company goals
Keeps equipment and work area clean and orderly
Ensure compliance with federal and state laws
Perform all duties in a safe manner

Quality Systems Manager Resume Examples & Samples

Creation and maintenance of HICSE’s Quality Management System to ensure delivery of quality products and services and compliance with the relevant quality standards
Maintenance and progression of HICSE’s Quality Accreditation
Adherence to the HICSE Business Management System to maintain and enhance customer satisfaction through processes and leadership
Identifying and recommending to senior management areas for improvement in the quality management system and the wider company at large
Guiding and preparing the company through external and internal audits
Ensuring that current and future HICSE products meet the quality requirements
The creation, implementation and management of the HICSE Quality Plan
Managing the HICSE Quality Team
Implementing and managing the HICSE Audit Programme and Internal Auditors
Managing the HICSE Quality Review Team and chairing Quality Review Meetings
Maintaining, monitoring and developing the HICSE procedures and systems and ensure their compliance to BS EN ISO9001, TickIT+, BS EN 50128 and other relevant standards
Measuring the application of quality processes and identification of areas for improvement
Reporting of relevant quality issues to the HICSE Management
Ensuring customer satisfaction through surveys to the HICSE Audit Programme
Implementing agreed improvement plans
Thorough knowledge of the HICSE BMS and other relevant quality standards
Internal Auditor qualification
Lead Auditor qualification
Good knowledge of BS EN 50128
Quality Management Qualification or relevant experience
Ability to communicate at all levels of the business, customers and suppliers

Quality Systems Manager Resume Examples & Samples

Bachelor’s degree or equivalent combination of educational background and work experience in Banking/Financial Services/Consumer Lending preferred
10 years of software quality assurance and test management experience and 5 or more years in a team leadership capacity with proven ability to lead testing projects of all sizes
Technology consulting background preferred with ability to lead and manage concurrent projects/teams and customer expectations
Strong background in development of solutions and/or supporting IT applications for diverse business needs
Prior experience implementing enterprise wide process improvements in support of testing and software development
Deep understanding of the software development lifecycle through deployment
Proven ability to lead testing projects of all sizes
Experience with Shaw Retail, Shaw Collections, or Shaw Leasing system or similar consumer lending platforms are highly desired
Good written, oral communication and interpersonal skills
Strong teamwork skills; ability to positively contribute to the overall success of the project team

Senior Quality Systems Manager Resume Examples & Samples

Experience managing or working within Quality Management System
Experience leading/receiving external inspections
Experience working in a regulated environment
Skill in multiple computer based tools and software programs such as Word, PowerPoint, Excel, Visio, MS Project or site builder etc
7+ years of quality, manufacturing, or regulatory experience
5+ years of progressive leadership experience
Experience with ISO 13485 and FDA 21CFR820, Quality System Regulation
7+ years’ experience within Quality Systems or Quality Assurance responsibilities or equivalent
Experience at managing large projects and influencing stakeholders at all levels
Experience at facilitation, consensus building and/or conflict resolution
Experience in business process development
Master’s Degree (MBA/MAOL)
Working knowledge of process improvement skills including Six Sigma, Lean Sigma, Knowledge Management and Process Design
Strong project and time management skills
Proven experience in achieving results through influence, management and motivating teams
A thorough working knowledge of the following: ISO 14971; Medical Device Directive; and other applicable Standards that apply to medical device design, development and manufacturing
Organizational Change Management Certifications or experience putting Change Management models into practice

Corporate Quality Systems Manager Resume Examples & Samples

Manage Corporate Quality Document Control Product Configuration Specialist (Change Analyst) function, ensuring timely and accurate processing of Engineering Change Requests and Temporary Change Authorizations
Provide quality system technical support for the Quality System Simplification Project team, including writing and editing procedures and related documents
Provide project management support for the Quality System Simplification Project team, including overseeing the activities of the Quality Specialist responsible for coordinating the project team (e.g., scheduling meetings, issuing minutes and following up on action items, creating executive slide decks, maintaining repository of all project related documentation on Sharepoint site)
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Representing Quality System Simplification project team as designee of team leader to deliver executive updates and other communication activities
Bachelor's degree required, preferably in a science or engineering discipline
Requires a minimum of 10 years of experience (or Master’s degree with 8 years) in a medical device or pharmaceutical quality system (QSR/cGMP and ISO 13485) supervisory, decision-making role
Project Management Professional (PMP) certification preferred
Lean/Sigma Green Belt or Black Belt preferred
ASQ certification (e.g., Biomedical Auditor, Quality Manager) preferred
Results-oriented, positive “can do” attitude with demonstration of appropriate urgency
Highly detail-oriented with demonstrated understanding of broader context, priority and significance
A hands-on individual who enjoys challenge, is capable and dedicated to getting the job done with minimal direction
Demonstrated track record of developing talents of self and others, including performance management
Strong interpersonal relationship skills including negotiating and relationship management
Ability to translate highly complex and technical information to all levels of the organizations via training module development and delivery

Plant Quality Systems Manager Resume Examples & Samples

Develop and implement the site specific Quality Systems and Food Safety Plan including Quality Management strategies, direction, and policies with the goal of protecting the business, reducing variation and waste, and growing the business
Accountable for ensuring compliance with Colgate /Hill’s Quality Standards, Local, Governmental, and International Quality and Environment, Occupational Health & Safety (EOHS) and Regulatory standards and guidelines and will interface with all agencies to communicate, address, and resolve any issues
Responsible for execution of Environmental and Micro programs and the Cleaning & Sanitation (C&S) Program at the facility both on finished goods and processing / packaging equipment
Responsible for reporting Key Performance Indicators (KPI’s) of Quality systems both internally and externally on a monthly basis or higher frequency as determined by business
Accountable for the robustness of key Quality Systems including but not limited to Incoming Component & Finished Product Inspection & Release, Validation, Corrective and Preventative Action (CAPA), Change Control, Internal Audits, Laboratory Management and Documentation Management
Manages the development and implementation of the site’s Quality Audit program to ensure conformance with standards, quality-related regulatory requirements, Good Manufacturing Practices (cGMP’s), and leads the development and implementation of Continuous Improvement (CI) and action plans to address any internal/external quality or food safety audit findings
Support implementation of Quality Assurance and Food Safety Initiatives and ensure personnel adhere to Hill's policies, safety standards and cGMP's, including Quality Assurance and Safety
Accountable for the site’s consumer satisfaction programs such as consumer complaint tracking and reduction of plant controllable complaints
Administers all Performance Management and Coaching / Feedback activities and provides effective career development and planning for all members of the Quality Team at the site
Participates with other Plant Managers and Corporate Quality on continuous improvement projects
Functions as a key member of the Site Strategic Team which supports the plant’s vision, provides resources to achieve plant strategy, ensures decision making processes are consistent with guiding principles, establishes clear direction and CI expectations, leads and supports change for the plant
Prepares and manages operating budgets for variable and fixed overheads for the Plant Quality Team
Bachelors Degree in Chemistry, Engineering, Microbiology, Biochemistry, Food Science or a related technical field
8+ years' work experience in Quality, Supply Chain, Research & Development or other technically related field
3+ years' work experience in a food manufacturing facility
3+ years' supervisory experience
Prior direct experience and active participation in an audit inspection by a regulatory agency
1+ years' project management leadership experience
Master's Degree in Chemistry, Engineering, Microbiology, Biochemistry, Food Science or a related technical field
7+ years' experience in Quality, Supply Chain, Research & Development or other technically related experience
5+ years' experience in a food manufacturing facility
5+ years' supervisory experience
5+ years' experience with the Hill's product portfolio and business systems

Quality Systems Manager Resume Examples & Samples

1 In conjunction with other departments, creates and monitors QC systems which assure that all in-process and finished goods meet established government, Mondelez and internal specifications, as well as being manufactured in accordance to all Food Safety Measures
2 Maintains current knowledge of cereal chemistry, promoting and executing new application of analytical tools
3 Performs fact-based assessments/audits of Manufacturing Systems ensuring that all records, procedures, processing, packaging and equipment are in compliance with all federal, state and other regulatory requirements
4 Assists in the development of new quality/regulatory systems and personnel and also serves as a resource for plant quality and manufacturing functions
5 Responsible for leading facility internal audit process
6 Will lead the QA Pillar in an IL6S environment
1 Change management skill building
2 Enhanced knowledge of customer service policies, procedures and programs
3 Solid knowledge of IL6S/TPM with proven experience
4 Excellent change management skills and High Performance Work System
1 Motivating others
2 Developing direct reports & others
3 Problem solving refinement
Bachelor in Quality, Business Administration, Food Science or related fields
Proved experience leading and managing a diverse workforce
Advanced experience in production manufacturing quality sanitation experience
Leadership in a Team Environment

Quality Systems Manager Resume Examples & Samples

Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training and appraisal of QS staff
Responsible for processes within Document Control, Customer Quality and Master Data area
To take a leadership role in driving improvement initiatives in the Quality Management system across the site
Drive and enhance a compliance culture though-out the site
Providing Quality Systems support for all business units and sites
Preparing for and supporting external audits (TUV, FDA, customer etc)
Ensure adequate monitoring and measurement of processes, and reporting same to management
Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organization
Be responsible for Health & Safety within assigned areas
Any other duties assigned from time to time

Quality Systems Manager Resume Examples & Samples

Quality Management and Leadership - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Quality System Development, Implementation and Verification - Communicate quality management philosophies (e.g. Deming) and lead tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Use of these approaches routinely. Passed ASQ CQM (Certified Quality Manager) exam and/or have 4 years’ experience in this area
Plan, Control and Assure Product and Process Quality (was Inspection and Audit) - Knowledge of basic quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement
Problem Solving - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Five Core Tools: Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode Effect Analysis (FMEA), Measurement System Analysis (MSA) and Statistical Process Control (SPC) - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Six Sigma - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Project management - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Basic computer skills including MS Office, Notes, QSI and CQMS - Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Knowledge of the applicable standards for the organization (i.e., ISO/TS, etc.) -Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Internal Auditing - Communicate quality management philosophies (e.g. Deming) and lead tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Use of these approaches routinely. Passed ASQ CQM (Certified Quality Manager) exam and/or have 4 years’ experience in this area
Leadership (Persuade & Influence, Coach & Develop, Championing Change/Creating Global Mindset) -: Understand quality management philosophies (e.g. Deming) and tasks such as understanding customer and business needs, basic goal setting, planning processes and the use of results and customer satisfaction data for improvement. Able to demonstrate use of these approaches. CQE (Certified Quality Engineer), or with 2 years’ experience in this area
Bachelor of Science (or equivalent degree) in Engineering required and 2 - 5 years’ experience in Quality Engineering

Quality Systems Manager Resume Examples & Samples

Developing a team of quality professionals to support quality systems management objectives and ensure continual quality improvement
Exemplary oral and written communications skills
Working knowledge of cGMP’s and regulations
Proficiency in Microsoft Word, PowerPoint, and Excel. Knowledge of Trackwise, ComplianceWire and Documentum software is required

Senior Quality Systems Manager Resume Examples & Samples

In depth knowledge of applicable Medical Device Regulation including but not limited to: 21 CFR 820, 21 CFR 806, ISO 13485, European Medical Device Directive, Canadian Medical Device Regulation (CMDR), and Japan Pharmaceutical Affairs Law, Agencia Nacional de Vigilancia Sanitaria (ANVISA)
Knowledge of effective root cause investigation including industry best practice methods, corrective and preventive action planning and execution and verification of effectiveness techniques
Strong analytical and decision making skills
Technical expertise facilitating front and back rooms for third party inspections
Influence management skills; ability to work constructively across all functions/level of the organization as well as external customers and regulators

Quality Systems Manager Resume Examples & Samples

Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, ISO 9001, ISO 13485/8, MDD, CMDR, Japan R-PAL and other quality requirements
Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements
Leads and/or supports initiatives to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System Policy/Procedures Manual
Supports and develops systems for the identification, analysis, correction, and prevention of quality issues
Contributes quality expertise to product development and manufacturing transfers initiatives to ensure effective compliance to the Product Development Protocol and other applicable requirements
Oversees and lead key quality systems processes to ensure its effectiveness which includes Quality Planning, Document Controls, Training, Audits, Change Controls, Process and Software Validation, Nonconformance CAPA, Manage External Requirement, etc
Manages, conducts and coordinates external (FDA, TUV, etc.) audits
Manages the design and manufacturing documentation and traceability systems
Provides QA support, participate and collaborate in division related projects
Works with local management team members in developing long and short-term business goals and strategies
Represents MSO on Global Quality Leaders Council, collaborate with peers across all BUs for global quality initiatives and works closely with peers on similar quality concerns between MDT sites
Minimum of 6 management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry
Overall operational and financial acumen, Business and Project Management skills and experience a plus
Familiar with Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO
Training in the following will be advantaged
University or Master Degree in Engineering or Science with relevant experience

Quality Systems Manager Resume Examples & Samples

Coordinate external audit program to ensure continued compliance with Medtronic, FDA’s QSR, ISO 13485, MDD, Guidelines on Medical Devices Vigilance System, CMDCAS, CMDR and other regulatory agency requirements. This includes audit scheduling, preparation, coordinating audits, preparing and distributing reports, follow-up activities for corrective actions and maintenance of external audit files and distribution of status reports to management
Manages activities of the Quality Systems group with responsibility for results in terms methods and employees. Oversees CAPA, internal audits, quality system procedure changes and management review processes
Frequent contacts with managers concerning projects, operational decisions and scheduling requirements. Conducts briefings and technical meetings for internal and some external representatives
Acts as an advisor to staff members to meet schedules or resolve technical or operational problems. Directly participates in establishing and administering many functional projects. Develops and administers schedules and performance standards
Exerts influence in the development of overall objectives and long-range goals of the quality systems organization
Ensures applicable standards and regulations pertinent to Medtronic Orange County are effectively implemented and acts as an advisor to all managers
Providing leadership and support for the development and implementation of internal audit root cause corrective actions
Contribute quality systems expertise to assist in continuous improvement activities throughout the Heart Valves organization
Establish and maintain a program for the training of employees on Quality System Regulations, ISO and Medical Device Directive, Corporate, and other regulatory standards
Lead initiatives to ensure effective quality reporting, quality systems, customer feedback (internal/external/regulators) and quality improvement efforts
Work with the local management team members in developing long and short-term business goals and strategies
Coordinate external audits (Corporate, External Regulators, FDA, and Notified Bodies) of the quality systems and other compliance activities. Follow-up on audits to ensure implementation of corrective actions and timely closure
Maintain facility certifications and establishment registrations to meet all regulatory requirements for the facility
Develop proficiency in quality system and regulatory requirements
Ensure effective and robust risk management for products and processes
Manage the Learning Management System for Medtronic Orange County
Approve site quality system changes
3+ years of progressive leadership experience in a quality functional area
5+ years medical device or highly regulated experience with 2+ years quality auditing, CAPA, quality management review and quality training
7+ years industry experience with 3 years quality auditing/CAPA/Training
Regulatory compliance experience with Quality System Regulations
Effective interpersonal skills
Solid knowledge of quality systems
Word processing skills
Experience in biological field and / or related to tissue valves
Knowledge in database management applications
MBA or MS Degree in Engineering, Physical /Biological Sciences
RAC or CQA Certification
Knowledge in the application of risk management

Senior Quality Systems Manager Resume Examples & Samples

Develop & maintain the Quality plan and metrics
Provide oversight and maintain the Quality System
Participate in the preparation and execution of site and BU management reviews
Provide leadership for site readiness for FDA or other Notified Body inspections
Provides leadership for the Configuration Assurance team
Guide site to increased understanding of 21CFR 820 requirements
Provide input and lead users in the effective and compliant use of the QMS architecture
Manages audits for (Regulatory Agencies, Notified Bodies, and Internal Audits)
Leads strategic Quality System initiatives. Responsible for establishing objectives, timelines and milestones
Set and manage clear project priorities based on compliance risk assessment and business prioritization
Drive the effectiveness of the Quality System by working collarboratively with other stakeholders to ensure effective and compliant processes
Foster a high-performance culture through active leadership and create a strong sense of accountability within the department
Ensure personal understanding of all quality policy/system items that are applicable
3+ years of progressive leadership experience
Experience with Class III finished medical device manufacturing
10+ years’ experience managing the Quality System and departmental activities within medical device or pharmaceutical manufacturing companies
Strong track record of successfully managing difficult tasks from start to finish. Independently determines and develops approach to solutions
Successfully manages multiple priorities efficiently and effectively to meet or exceed customer expectations
Excellent interpersonal skills and ability to influence others

Quality Systems Manager Resume Examples & Samples

Establish and implement a Quality System that complies with domestic and international quality system requirements and guidelines
Evaluate compliance of raw materials and processed product with specifications and customer requirements
Develop and implement a continuous improvement program for product quality
Review and approve process and product changes notices
Product Release
Document Control
Experience in a regulated industry
Knowledge of medical device regulations, statistical sampling and analysis, CQA/CQE
Strong oral and written communication, computer (Word, Excel)
Demonstrated leadership and communication skills

Quality Systems Manager Resume Examples & Samples

Responsible for managing and reporting on the quality systems and tools within NH including: deviation, change control management, CAPA, rsk management, document control and records management systems at NH
Develop and refine quality processes and NorthStar’s electronic QMS to meet business needs and continuous improvement
Co ordinate quality metrics and management review meetings. Actively participates in the meetings and follow up on actions
Responsible for ensuring systems are in place to ensure NH maintain compliance with quality and technical agreements and regulatory expectations
Manage the system for internal audits of the NorthStar group and ensure timely compliance
Ensure readiness and manage external audits of the NH quality systems
Manage a system for training for all NH personnel and the delivery of GMDP training
Set up and manage mock recalls and assist the Quality Director in the set-up and/or running of recall activities
Ensure a process is in-place for approval, oversight and management of outsourced services
Co-ordinate quality change control approvals from contract manufacturers
Create & maintain a culture of quality & continuous improvement throughout the organisation
Assist in the preparation of quality and technical meetings and prepare reports and metrics as required by the business
Oversee and provide direction to the Quality Systems personnel
Work closely with the management team to support the growth and development of NorthStar
Proven management experience
Full understanding and knowledge of cGMP, quality Assurance and regulatory principles in a pharmaceutical manufacturing environment
Excellent knowledge of US and European regulatory requirements
Experience in managing Quality Assurance and quality systems in FDA and HPRA based Pharmaceutical manufacturing essential
Strong knowledge of pharmaceutical manufacturing in at least one dosage form
Proven auditing skills while not a requirement are an advantage
Ability to manage and direct the cross-functional quality function team
Excellent knowledge of quality management systems
Strong communication skills with ability to communicate at all levels within the Organisation
Proven analytical skills and problem solving skills
Technical writing ability and strong presentation skills
Ability to work effectively with others to accomplish goals
Understanding of customs and beliefs of other groups or cultures is an advantage
An understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately is also required
Excellent organisational skills and attention to detail
A self motivated and results orientated individual with the ability to meet deadlines
Knowledge of computer system validation while not essential is advantageous

Senior Quality Systems Manager Resume Examples & Samples

Process owner for the Internal Audit program and procedures. Working on enhancing the efficiency and effectivity of the Internal Audit program
Process owner for the CAPA system and the CAPA Board meetings held with MI management
Leading continuous improvement of Siemens Molecular Imaging Quality Management System through the implementation of robust Internal Audit and CAPA programs
Scheduling, planning, and conducting of internal audits at Molecular Imaging sites in Illinois and Tennessee
Communicating audit results through closing meetings, Management Review updates, and audit reports
Actively managing CAPAs that result from Internal Audits. Providing feedback and guidance to CAPA Owners on corrective and preventive actions
Tracking implementation of corrective actions and performing effectiveness verification activities related to audit findings
Supporting external audits including interfacing with regulatory agencies such as FDA, ANVISA, TUV, and BSI
Staying informed of new and upcoming regulations and industry trends and gathering industry intelligence through reviews of publications, regulatory conferences, and FDA 483s and Warning Letters issued. Properly adjusting the compliance activities at Siemens Molecular Imaging
Supporting CAPAs related to external audit findings
Conducting site planning and training in preparation of notified body audits and FDA inspections
Performing and presenting trending related to the CAPA and internal audit processes
Must be familiar with all elements of a Quality Management System, in particular the Corrective and Preventive Action sub-systems
Must be knowledgeable in FDA’s QSRs, ISO requirements, MDD, and CAMDCAS requirements
Must have experience with CAPAs as an owner and/or approver
Must be reliable and capable of working with minimal supervision to manage audit planning, execution, and follow-up activities
Must be able to manage controversial issues that may arise from internal audits through constructive communication with cross-functional teams
FDA and Notified Body audit exposure is preferred
Must be highly compliance oriented to firmly adhere to the principles of the regulations and standards
A Bachelor's Degree in a technical discipline such as Electrical Engineering, Mechanical Engineering, Nuclear Medicine or a clinical discipline
Medical Devices regulations knowledge and experience required
Internal Auditor Certification preferred
Travel Required: About 25%

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Quality Systems Manager Resume Examples & Samples

Quality Systems Manager Resume Examples & Samples

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