Quality Management Systems Resume Samples

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H Boyer

Haleigh

Boyer

45573 Hermiston Islands

Boston

+1 (555) 406 5924

45573 Hermiston Islands

Boston

Phone

p +1 (555) 406 5924

Experience Experience

Detroit, MI

Quality Management Systems Coordinator

Detroit, MI

McGlynn, Greenholt and Boehm

Detroit, MI

Quality Management Systems Coordinator

Maintain tracking to allow for proper corrections of internal and external audit major/minor non-conformances and improvement observations in accordance with Plant and Faurecia Standards
Support administrative resources across the organization to ensure consistency, linking process and documents, removal of duplication and provide advise on efficiency related matters
Assist all department Management personnel in the development of systems to comply with TS, FES, Q1, and Faurecia Standards
Develop training packages and deliver training for process/document content managers
Develop and Manage document control systems
Management of Div. A Global Policy Manual and alignment with ZF Quality Management System
Review process and documentation to ensure quality frameworks, forms, references and links are established

Dallas, TX

Quality Management Systems Manager

Dallas, TX

Bartoletti, O'Kon and Pfeffer

Dallas, TX

Quality Management Systems Manager

Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope
Site CARISMA Management
Audit Program Management and execution
Familiar with Quality Systems (Example: CAPA, Change Control, Risk Management etc)
Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope
CAPA management for the site
Management and Coordination of Change Controls for the Site

present

Los Angeles, CA

Cmmi Quality Management Systems Senior Engineer

Los Angeles, CA

Stracke-Haley

present

Los Angeles, CA

Cmmi Quality Management Systems Senior Engineer

present

Knowledge of Quality Management Systems, project management and problem resolution
Provide internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements.
Develop and implement system improvements to maintain process excellence through Measurement & Analysis
Develop and document procedures and action plans to define new systems and continually improve existing systems
Provide leadership and guidance to ensure leading edge business practices are defined and implemented
Support QMS Manager by driving QMS initiatives and leading teams
Facilitates management of QMS resources and objectives, including: Regulatory Compliance, Internal Audits, Corrective and Preventive Actions (CAPA), Business Process Improvement support, QMS Metrics and Records

Education Education

Bachelor’s Degree in Engineering

West Virginia University

Bachelor’s Degree in Engineering

Skills Skills

Strong working knowledge of AS9100 quality standards
Strong technical writing skills, the ability to communicate effectively with management, technical teams and all organizations in the business, and strong problem solving skills
Highly motivated, quick thinking, and able to convey ideas and present unconventional solutions to unique problems
Ability to work independently with a strong work ethic, be innovative, detail oriented, possess initiative, be positive, and be people oriented
Knowledge of control of nonconforming hardware, failure/root cause analysis, and corrective and preventive action processes
Consultative approach to problem solving to provide solutions and make independent judgements for process improvement
Demonstrated competence in working with diverse personnel to resolve issues with short deadlines
ASQ Certification (CQM, CQE, CQA, RAB), ISO/AS9100 certified / trained auditor

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Analyst, Quality Management Systems Resume Examples & Samples

The incumbent should possess experience and knowledge in
Knowledge of health care operations, with a focus on quality management, patient relations and risk management services in acute and non-acute outpatient settings is strongly preferred. Includes structure, department-specific policies and procedures and workflows
Demonstrated knowledge of information technoogy, including management of databases, experience as second or third level technical support, troubleshooting and system maintenance preferred
Prior experience in the use of information system applications in the practicing health care environment is required. Healthcare applications or relevant professional experienece as typically acquired in 3 to 6 years
Strongly prefer in-depth experience with Midas, including Quality, Patient Relations, and Risk modules
Experience with Statit PPR, Statit PiMD, and Epic is beneficial
In-depth of knowledge of application environments including production, test and interfaces is preferred
Ability to be involved in, and prioritize multiple projects at the same time
Excellent organization skills; ability to prioritize multiple activities and objectives in a rapidly changing environment, and deliver quality service. Project management experience strongly preferred
Ability to work effectively with health care application users, vendors, and technical professionals
Excellent teamwork and collaboration skills are required
Must be able to take direction, or be self-directed as the situation requires
Excellent communication skills, oral and written, are required. Includes ability to convey salient points to technical and non-techincal audiences concisely in presentation materials
Strong evidence of critical thinking skills. Creative, independent and inquisitive
Strong knowledge of word processing, spreadsheet and presentation computer programs, preferably Microsoft

Cmmi Quality Management Systems Senior Engineer Resume Examples & Samples

Support QMS Manager by driving QMS initiatives and leading teams
Facilitate development of advanced quality concepts to enhance QMS, business process, tools and measures
Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices (i.e. Six-Sigma, Lean Methods)
Facilitates management of QMS resources and objectives, including: Regulatory Compliance, Internal Audits, Corrective and Preventive Actions (CAPA), Business Process Improvement support, QMS Metrics and Records
Provide leadership and guidance to ensure leading edge business practices are defined and implemented
Work with integrated teams to develop creative solutions to systems problems and improve key process activities/initiatives measurably and enhance overall business practices
Develop and document procedures and action plans to define new systems and continually improve existing systems
Provide internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements
Lead and/or facilitate QMS third party regulatory audits (ISO9001, AS9100, CMMI)
Lead and/or facilitate internal and external audits (CMMI, AS9100, regulatory, customer, etc.). Review corrective action plans
Develop and implement system improvements to maintain process excellence through Measurement & Analysis
Implement, monitor and measure business process improvements to maintain process excellence and QMS compliance
Develop innovative and practical solutions to complex and unique process problems through the use of best practices (i.e. Six-Sigma, Lean Methods)
Work with integrated teams to measurably enhance overall business practices
Requires a bachelor's or master's degree in engineering, business, quality system or technical field and experience working in a technical industry, preferably aerospace or related discipline and ten or more years of related experience with a bachelor's degree or six or more years with a master's degree. May substitute equivalent experience in lieu of education
Formal training in Six Sigma, AS910-0 and CMMI preferred
Must demonstrate a detailed working knowledge and understanding of QA principles, concepts, theories, regulations and practices; extensive knowledge of ISO 9000/AS9100 or similar quality system
Must possess ability and project management skills, including organizing, planning, scheduling, prioritizing to meet established deadlines and milestones
Must possess the ability to resolve complex technical and systems issues
Must have strong verbal and written communication skills to accurately document, report and present findings; and, strong interpersonal skills to effectively interface with all levels of employees, management and outside representatives
Must be able to work on a self-initiated basis and in a team environment, and be able to work extended hours
Travel may be required, not exceed 10%
Knowledge of Quality Management Systems, project management and problem resolution
Six Sigma belt certification, ASQ CQE and/or formal training in CMMI V. 1.3 preferred and training on Lean Manufacturing methods
MS Suite, including MS Project, SharePoint, SAP and/or Oracle experience
Experience in team facilitation and root cause analysis and resolution
Proven QMS Leadership experience
Ability to develop creative solutions to complex systems issues

Manager, Quality Management Systems Resume Examples & Samples

Manage the QMS resources and objectives, including: Regulatory Compliance, Internal Audits, Corrective And Preventive Actions (CAPA), Business Process Improvement support, QMS Metrics and Records
Develop innovative and practical solutions to complex and unique process problems through the use of best practices (i.e. Six-Sigma, Lean Methods). Work with integrated teams to measurably enhance overall business practices
Quality engineering or management experience working in the DoD or aerospace industries is required
Proven QMS Lead or Management experience
Ability to develop creative solutions to complex systems issues. Database management skills
Extensive experience in management, team facilitation, and training of all levels of the organization
Formal training as an ISO9001 or AS9100 and CMMI v1.3 Lead Assessor, Lean Manufacturing methods, UAV product and/or technology experience
Typically requires a Bachelors, Masters or PhD in engineering or a related technical field as well as thirteen or more years of progressively complex QA experience with at least seven of those years having management responsibilities. May substitute equivalent experience in lieu of education

Manager Quality Management Systems Resume Examples & Samples

Lead the development, continuous improvement and implementation of Quality Systems
Improve Change Control, Supplier Management and CAPA processes
Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes
Establish and track quality metrics for QMS processes and present improvement opportunities at Management Review meetings
Implement risk management based approaches
Conduct domestic and international Quality System audits (e.g., CMO Qualification, Assessement, For Cause, and/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH and other regulatory bodies as may be required and remain GMP inspection ready at all times
Interface with FDA / EU and other regulatory agencies, customers and consultants
Represent QA on cross-functional teams to complete projects, address quality issues and implement quality system improvements
Identify compliance gaps and leading focused teams to resolve compliance issues. Provide written compliance assessments to management on request, and interpreting global regulations and applying them to a multi-product, multi-modality environment
Develop, or review, Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and all other applicable global regulatory requirements
Establish and oversee internal quality systems and policies throughout the company
Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, CMO’s, vendors and investigator study sites
Prepare GXP quality metrics; analyze data relating to process validations, process controls, and continuous process improvement efforts; coordinate the necessary quality adjustments
Provides QA support to IT projects as needed

Senior Quality Management Systems Analyst Resume Examples & Samples

Drives cross-functional and global collaboration relative to HCBG QMS documents
Develops and implements standardized documents in collaboration with QMS process owners, HCBG divisions and global sites
Performs technical review of new and revised documents and manages existing documents
Leads projects relative to QMS documentation
Maintains ENOVIA and provides administrative support to users
Uses analytical and administrative skills to analyze and evaluate documentation needs, interpret and apply applicable regulations
Applies leadership and change management / influencing skills when working with all levels of employees to buy into concepts and to allow them to increase knowledge, learn new skills, adopt new behaviors, and to skillfully negotiate team problems to a win/win resolution
Negotiates and counsels an audience which may not be knowledgeable in the subject area to help with change management, thereby demonstrates solid persuasion skills and manages differing interests and perspectives
Bachelor's degree or higher from an accredited institution
Experience working in a Documentation, Quality Management System (QMS), Quality and/or Regulatory environment
Bachelor’s degree or higher in a Science or related discipline from an accredited institution
Minimum of two (2) years of QMS, Quality and/or Regulatory Affairs experience
Previous experience working in a Food and Drug Administration (FDA) regulated device, combination, or drug environment or other regulated industry
Strong demonstrated project leadership ability and the ability to lead teams and drive change
Ability to multi-task and prioritize with strong analytical and problem solving skills
Ability to identify opportunities for improvement and lead change
Experience in Lean Six Sigma
Proficient in technical review and writing, communication, and collaboration
Microsoft Office proficient, experience with administration of ENOVIA or another document management system

Manager, Quality Management Systems Oversight Resume Examples & Samples

A minimum of a Bachelor of Science (BSc) (or equivalent degree) is required
A minimum of 8 years of relevant experience in a medium to large scale matrix organization within the Pharmaceutical, Medical Device, and/or Consumer/OTC sector
Knowledge of global GxP compliance regulations governing clinical development activities is required
Extensive knowledge of quality and risk management terminology and proficient knowledge of scientific terminology is required
Strong knowledge of the CAPA process is required
Ability to operate in a matrix environment and influence and colleagues cross functionally on a regular basis is required
Excellent organizational, analytical, strategic, interpersonal, written and oral skills required
Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required
Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required
Fluency (both written and oral) in English is required. Fluent means that you are completely comfortable communicating on a detailed, professional level
This position will be located at any Janssen facility worldwide and may require up to 10% travelR&D

Director of Waiver Quality Management Systems Resume Examples & Samples

Extensive knowledge of Quality Management and Improvement system design and implementation
Extensive knowledge of current trends and best practices in delivering services to individuals with intellectual disability, acquired and/or traumatic brain injury and physical disabilities
Knowledge of CMS HCBS Community Rule
Extensive knowledge of CMS HCBS Waiver requirements
Knowledge of DDS/MRC policies, practices and regulations
Ability to understand, apply, and interpret the provision of the laws, rules, regulations, policies, procedures, specifications, standards, and guidelines governing agency operations
Ability to write concisely, to express thoughts clearly, and to develop ideas in logical sequence
Ability to write general, statistical, and technical reports
Ability to analyze and determine the applicability of program data, to draw conclusions and to make appropriate recommendations
Ability to gather information by examining records and documents and by questioning and observing individuals
Ability to anticipate and analyze difficult situations and take corrective action to prevent problems from occurring

Quality Management Systems Specialist Resume Examples & Samples

Lead the business group's efforts to maintain and enhance the ISO 9001 systems by working with global quality, external registrars, and the sites serving as the group Management Representative
Lead the efforts to maintain and enhance the RCMS certification by working with the EHS organization, registrars, and the sites
Lead the business group's efforts to maintain and enhance the additional Quality Management Systems (QMS) including European Federation for Cosmetic Ingredients (EFfCI) certifications and Round Table for Sustainable Palm Oil (RSPO) certifications by working with global quality, external registrars, and the sites
Champion the adoption of "best practices" in the quality arena across all Care Chemical North American locations
Champion quality initiatives to drive continuous improvement (5S, 6 Sigma, Lean, TQM)
Coordinate external ISO and RCMS audits and where applicable EFfCI and RSPO audits
Coordinate and conduct internal ISO and RCMS audits and where applicable EFfCI and RSPO audits
Maintain the Care Chemicals Group level quality documents (i.e. the Quality Manual and supporting documents) and the EM Quality webpage
Coordinate external customer quality audits to insure the best use of site and business resources
Oversee the completion of standard EM training efforts in Florham Park

Quality Management Systems Coordinator Resume Examples & Samples

Manage the building and maintaining of the site TS and Q1 systems to allow certifications
Develop and Manage document control systems
Support the Management team in the application of Layered Process Audit (Kamishibai) methodologies by providing training and coaching on system requirements
Assist all department Management personnel in the development of systems to comply with TS, FES, Q1, and Faurecia Standards
Transfer knowledge and experience to Plant Personnel through improvement activities
Maintain tracking to allow for proper corrections of internal and external audit major/minor non-conformances and improvement observations in accordance with Plant and Faurecia Standards
Chair monthly review meetings to review and track improvements for TS and Q1 system requirements
Supervise Lab Technicians and support measurement activities
Ensure Lab personnel maintain all calibrations of tooling on time, per Gage Track software
Assist Quality Engineers by using the Lab Technician to develop and maintain SPC for product characteristics
Prioritize Lab Technician testing responsibilities to meet Customer and Faurecia testing time lines
Work to improve lab testing instructions and testing capabilities
Ensure Lab Technician is trained to perform all Customer required testing to a minimum of a Level U in Polyvalence
Complete cross training of Quality Technicians to perform Lab Testing
Results oriented with strong written and oral communication skills
Basic skills in Microsoft applications (Excel, Word, Outlook, Powerpoint)
Ability to work in a matrix organization
Proficient level of English
Preferred Experience as a ISO/TS Lead Auditor

Senior Quality Management Systems Officer Resume Examples & Samples

CAPA management
APR/PQR creation
Regulatory requests
Material Assurance
Production of site and department metrics
To provide support to Quality Management during customer and Regulatory audits
To participate in the programme of internal auditing of Catalent UK systems and procedures
To provide support with supplier assessment program

Quality Management Systems Expert Resume Examples & Samples

Maintain and develop LabWare application(s) and be capable of supporting and developing SAP QM functions
Develop, with the domain leader, a coherent structure and vision for the future for the applications in the domain
Must be capable of performing project management functions like budget management, resource balancing and project time tracking
Responsible for oversight of both regional and WW sites Function as an escalation point for stream/domain related issues at supported locations, subjects unable to be treated by CGI (SAP) or Infogène (LabWare)
May be called upon to lead (project manage) LabWare and/or SAP QM projects and to provide IT related recommendations and solutions. This includes recommending and implementing solutions in phase with the direction of the stream (I & P)/domain (QM)
Will be called upon to leverage specific areas of expertise and to participate in regional/global projects
Will function as a liaison between site management teams and domain/stream to assist in helping sites determine needs and to plan for any required enhancements to meet needs of future projects
Will be a contributing domain team member responsible for promoting, implementing, and enforcing corporate standard policies and procedures
Capable of specifying and validating SAP and LabWare developments and be at ease with Solvay's standard tools and procedures
Bachelor degree in Information Technology or a related field. Equivalent experience may be considered
3+ years’ experience in Information Technology with a minimum of one year experience working in a QM IT based background of LabWare and/or SAP QM
Must be a US Citizen or green card holder due to ITAR restrictions
Prior relevant experience in LabWare applications and SAP QM functions
Strong interpersonal skills, a high degree of self-motivation, and the ability to work independently with minimal supervision
Ability to travel approximately 30%-40%
LI-EP1

Corporate Operations Development & Quality Management Systems Auditor Resume Examples & Samples

Bachelor's degree or equivalent in an engineering discipline and 10 or more years' experience in operational development and/or audit positions
Strong English communication skills (written and spoken) – Spanish capabilities are a big plus
Strong background in and understanding of an aerospace-centric operations and quality management systems
Strong experience in audit technics, you have developed during your experience rigor and autonomy

Quality Management Systems Manager MRO Network Resume Examples & Samples

Maintain the QMS and all Civil and Military approvals for MRO Network activities and to get new certifications allowing contracts applications
Perform Quality System Activities as requested by MRO Network applicable regulation. Manage the QMS and any existing Q delegation process
Verification of compliance with the MRO procedures by all the personnel
Control and follow-up of discrepancies and corrective actions of the maintenance activities
Execute, control and follow-up of audits and periodic inspections
Control of MRO Network Subcontractors (on aircraft activities)
To control the compliance of requirements of MRO Personnel for licenses. Control of the delegated Q activities if any
Update or create MRO process documentation such as procedures, manuals, etc. in accordance with the state of the art for customer and authorities
Perform the customer surveys
At least 2 years of experience in quality
Ability to take initiatives and autonomous profile
Strong listening and analytical skills

VP Quality Management Systems Dental Platform Resume Examples & Samples

Incorporates industry best practices and defines standard work for consistent and reliable quality systems execution across Dental Platform
Foster and maintain strong relationships with senior RAQA Regulatory leaders across DHR and leverage best practices and opportunities to drive cross business collaborations and initiatives
Plan and execute effective platform RAQA level Policy Deployment, leads implementation of key quality objectives and plans, including developing metrics to monitor, improve and sustain performance
Direct compliance activities to ensure conformance to Dental Platform quality standards
Leads and assists in preparation for and support of external regulatory audits including FDA, notified bodies, etc., as well as internal audits
Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RAQA as well as across the broader organization
Creates an environment that attracts, develops, and retains high quality employees, foster employee engagement, diversity, professional development and high levels of employee satisfaction
Must have comprehensive knowledge and experience with global regulatory requirements and product registrations
Must possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process
Track record of anticipating potential problems through effective analysis and proactively seeking solutions

Senior Quality Management Systems Officer Resume Examples & Samples

Supplier Liaison
Where qualified, to participate in the programme of internal auditing of Catalent UK systems and procedures
Bachelor’s degree (or equivalent) or significant experience
Preferably at least two years’ experience in a GMP manufacturing environment
Prior experience within Quality or Regulatory advantageous
Knowledge of current EU Good Manufacturing Practice requirements
Computer literate (MS Office – Word, Excel, Powerpoint)

Quality Management Systems Specialist Resume Examples & Samples

Support the North America Quality Management System (QMS), its policies and programs
Bachelor’s or Associates degree in a technical field, preferably in the chemical industry
2 – 5 years of experience in ISO 9001 Quality Management Systems, or an equivalent combination of education and experience with other systems
Trained ISO 9001 internal auditor or willing to obtain training and certification
Knowledgeable in 6 Sigma DMAIC methodology and root cause analysis

Project Manager, Quality Management Systems Resume Examples & Samples

Extract, compile, and track/analyze data to generate reports within timelines
Interpret data from various sources using statistical technique and provide ongoing reports
Develop and optimize data collection and procedures
Lead project teams and leverage tools to develop efficient and compliant systems for quality operations
Lead implementation and monitor progress for objectives for continuous improvement and regulatory compliance
Support the training program for quality investigations. Trains investigators on Root Cause and Investigation
Provide support in FDA, ISO, Corporate, Customer and other inspections and audits
Communicate progress, status, and roadblocks as required
Responsible for the preparation and facilitation of the Quality Management Review meetings
Review and approval of GMP document including procedure revisions, change requests, protocols, and reports
Create, revise and review SOPs including compliance documentation initiation, revisions, and deletions
Function as a process owner for CAPA and NIR systems
Support Quality Management System activities including but not limited to: internal audits, process improvements, tenders and customer surveys
Degree in Life Sciences preferred
6+ years in Medical Device industry with GMP experience
Knowledge of medical device FDA regulatory requirements and standards
Expert ability for use of software tools (including but not limited to: Minitab and Excel) for data analysis; advanced technical writing. TrackWise experience is preferred
Statistical technique experience is preferred
Good leadership and communication skills; teamwork orientation
Experience in participating in the management of regulatory audits
Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), or Certified Biomedical Auditor (CBA) desired
Expert ability for use of software tools for data entry and analysis; advanced technical writing skills
Must be highly organized and possess excellent attention to detail
This position reports to the Manager, Quality Management Systems
The position directly affects the processes, practices, and standards for the quality management system. Provides leadership and represents the department in cross functional teams

Project Manager Quality Management Systems Resume Examples & Samples

Direct and Lead projects with cross functional teams using leading practices to develop and deploy effective quality management systems at HHI
Prioritize quality systems projects based on strategic directives from leadership, cost, resources, timelines to implement the most effective corporate quality solutions possible
Serve as Program Manager on Strategic Projects and provide visibility to Senior Management during quality management reviews
Lead and ensure effectiveness of global quality foundational tools and methods: Request for Investigations (RFI), Request for Corrective actions (RFCA), Failure Analysis (FA), New product Introduction (NPI) and Product Qualifications (PQP) , Corporate/plant/supplier deviations, Quality integration with Product Lifecycle management (PLM), Material Review Boards (MRB) and scrap Cost of Quality (COQ), Global critical process capability monitoring (KPI), Asset and manufacturing process control automation
Define Measure, Analyze, Improve and Control the global QA metrics streams and visibility systems to enable quality monitoring and improvement
Provide support and assistance to the quality engineering teams ensuring resolution of product or process quality issues affecting HHI quality brand
Lead and ensure effectiveness of the Quality hold, rework, and escalation systems including leadership and customer communication tools and processes
Direct, implement and provide training to ensure advancement of global procedures, criteria and process standardization
Utilize Microsoft Project or equivalent software to manage all phases of semi-complex to complex projects
Travels as required by various work assignments
Off-shift work as required to successfully complete projects on-time and on-budget
Bachelor’s degree in business or technical field (Engineering, Operations) MBA or advanced degree desired
5-7 years plus experience leading corporate and operational quality system implementations
Project management experience with medium to large projects
Change Management experience and leadership within a matrix organization
Effective computer skills, interpersonal skills and communication skills are essential. Must be familiar with Microsoft Windows applications, especially Word, Excel, and Outlook. Experience with Microsoft Project and enterprise planning software desired
Good to Excellent interpersonal skills and communication skills
Ownership – Takes responsibility for the all outcomes of objectives and generates empowered teams
Risk Taking – Takes reasonable and well thought through risks. If mistakes occur initially, learns from them to increase future success. Takes initiative and isn’t afraid to take untested or new approached and actions
Urgency - Does what can and should be done right now as quickly and effectively as possible
Raise The Bar - Does better every time and every day in every situation. Creates and accomplishes continually increasing standards of excellence

Quality Management Systems Manager Resume Examples & Samples

Ensures compliant and effective QMS’s are maintained in scope
Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure
Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope
Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope
Ensures Q&R requirements are effective in all processes in scope
Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope
Audit Program Management and execution
Internal auditing and reporting
Audit NC follow up and closure until effectiveness verification

Quality Management Systems Manager Resume Examples & Samples

Coordination, organizing and managing L3 & L4 Audits as well as coordinating, managing /reporting /follow-up of Regulatory /Corporate (level 4 & Level 3) audits
Audit follow up and participation in team problem solving and implementation of outstanding issues arising from the audit
Recommend changes in practices to enhance conformance to GMP
Training in GMP and Quality / GMP related SOPs
Management and Coordination of Change Controls for the Site
CAPA management for the site
For all GSK KL related contractors: conduct GMP Training
Site CARISMA Management
To lead and prepare site to maintain ISO 13485 certification
Bachelor of Science or equivalent
Exposure in Quality Control/Quality Assurance function
Familiar with GMP/GLP requirements
Familiar with Quality Systems (Example: CAPA, Change Control, Risk Management etc)
Posses good interpersonal, motivational and communications skills to allow effective liaison with in house and external parties
Willing to learn attitude

WW Manager, Quality Management Systems Resume Examples & Samples

Integration of IT solutions to effectively meet the requirements of the Quality Management System
Utilize project management skills to establish and continually improve technology-based systems
Provide project management for the Business to implement new IT technologies or configuration of existing platforms to meet business needs
Represent the company on MD Sector or Enterprise teams involved in leveraging and developing IT solutions
Develop strategies for integration of Quality System & other IT systems
Manage acquisition and divestiture QMS projects for DePuy Synthes
Develop roadmap and strategy for ensuring QMS is prepared for emerging and disruptive technologies
A minimum of 10+ years of quality and/or manufacturing experience in life science industry
Project Management experience, preferably related to Information Technologies/Data Management systems
Working knowledge of Quality System processes
Strong communication, teamwork, and problem solving skills
Above average computer skills and command of commonly used business applications (i.e. Microsoft Office). Experience with SAP, EtQ, TrackWise, Product Lifecycle Management, and Learning Management Systems would be an advantage
This candidate should have a proven track record implementing large Quality System improvements to meet compliance and overall business goals
30% travel000019KI

Subject Matter Expert for Quality Management Systems Resume Examples & Samples

He/she is expected to have a deep understanding of QMS Professional
The understanding of QMS Professional is intended to be around the implementation (services) of these products across one or more related industries/domains
The role requires a passion for helping customer achieve realized value, a vision for improving Siemen’s position in the Manufacturing Operations marketplace, a desire to increase our market share in industries that we serve, and a drive for continuously improving the processes that we use to achieve successful implementations and the willingness to travel globally
This role will report directly to the Global Practice Lead for MOM Services. This Practice sits within our Global Services organization known as Digital Realization Services and will work extensively with the Zone MOM Services Delivery teams
Support implementation of new processes and methodologies ("Advantedge") across MOM Service globally
Develop/Harvest critical Advantedge Intellectual Property in support of MOM Adoption – Big Block, Solution Templates, Deployment Templates, Best Practices, etc
Provide subject matter expert (SME) support for Strategic Engagements
Solution Oversight and SME support for key campaigns/projects
Support the creation of strategies to enable Project Delivery in understaffed regions
"Blueprint" for executing strategic projects in countries with limited/no staff
Support the creation of strategies to build persistent capacity in understaffed regions
Develop and re-purpose assets to create Enablement Programs
Staff Enablement in support of scaling and aligning capacity
Leverage Advantedge artifacts to drive solution re-use and consistency
SME Support for capacity enablement (knowledge transfer and training)
Minimum Bachelor’s degree (Engineering degree preferred)
Minimum 3-5 years hands on experience implementing QMS products and MOM solutions (preferred: integration QMS to ERP, Shopfloor Systems (OPC) and Supplier/Customer Integration)
Minimum 5 years’ experience working with manufacturing-related industries (preferred: Automotive, Electronics, or Aerospace and Defense industries)
Deep understanding of Quality Management Solutions with an awareness of Manufacturing Operations Management Solutions (e.g. MES, APS, Scada)
Skilled with the architecture, configuration, and integration of Quality Management Solutions
Experience with implementing Advanced Product and Quality Planning (APQP), Failure Mode and Effects Analysis (FMEA), First Quality Inspection (PPAP), Statistical Process Control (SPC), Customer Complaint Management (CCM) and related Quality Process Management (QPM) solutions
Experience with querying SQL Server and Oracle databases
Strong customer and inter-personal skills, excellent German and English verbal and written communication abilities, the proven ability to gather and apply customer requirements, and the ability to quickly diagnose and troubleshoot issues
Travel is international and is expected to be as much as 70% at times – averaging around 50

Senior Specialist, Quality Management Systems Resume Examples & Samples

Improve the compliance for release/stability tests and methods for all Merck products globally by executing a strategy for harmonizing release tests and specifications from Legacy, Outsourced, and acquired products into the AS system
Support licensure and launch of all new products by creating AS to support manufacture
A strong analytical background with small molecule, vaccines, raw materials, or biologics experience
The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries
Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with Merck’s long term strategy
Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level
Thorough understanding of regulatory requirements for drug products and/or medical devices
Minimum 7 years experience in analytical laboratory for release testing or drug development
Use of the Trackwise Program for change control
Hands on experience running a variety of analytical methods, which would include two or more of the following: HPLC, densitometry, dissolutions, particle sizing, gel electrophoresis, spectrophotometric assays, immunoassays, cell based assays
Ability to accurately interpret and apply expectations for global compendia
Experience with CMC and product filings and the ability to accurately interpret and apply regulatory expectations to the AS
Previous experience creating AS as part of a product development team or commercialization team

Quality Management Systems Quality Engineer Resume Examples & Samples

Serve as focal for quality audits with third party auditors: Defense, Aerospace, and Customer auditors
Work with plant Managers to implement integrated quality management system and best practices
Work cross-functionally with other technical teams on projects related to the implementation, certification, and maintenance of the quality management system, and monitor the quality control system to ensure effectiveness and efficiency
Support quality management system policies and procedures through performing internal audits to assure compliance to company, customer and industry standards
Conduct root cause analysis and recommend corrective actions of quality management system deficiencies
Generate and review performance analysis reports regarding non-conformance of processes, root cause analyses, or quality trends; recommend actions, participate in team driven resolution and drive continuous improvement activities
Provide management with timely, complete and accurate reports of the current levels of conformity/implementation of the quality management system
Maintain a schedule of audit activity
Review and approve quality management system changes
Train other Personnel on auditing best practices
If you have an AS9100 Lead Auditor Certification or a Certified Quality Auditor (CQA) credential it is an added bonus (but not required)
Because we contract with the US Department of Defense we are bound by International Traffic in Arms Regulations (ITAR). This means you must be a US Citizen or Permanent Resident to be eligible

Solutions Architect for Quality Management Systems Resume Examples & Samples

Act as part of a Professional Services team, work productively with Consultants, Architects, Project Managers, and other internal & external interfaces to ensure that the customer succeeds in their objectives
As an Architect responsible for the translation of business requirements into MOM Software solution based on best practices in the subject area in order to deliver market-leading solutions and provide value to the customer
In line with project processes, interact with the customer to support the management of customer expectations and support customer adoption by leveraging the complete Siemens Delivery framework
Act as solution consultant to strategic Sales / Presales pursuits and Services projects, providing guidance through the complexity of solution architecture options and the long-term roadmap for the solution. Act as the ultimate authority on architectural design to address business problems
Provides direction for process design, process integration and process change activities either internally or at customer sites
Building customer relationships to achieve the role of a trusted advisor
Coaching junior consultants, being part of our coaching network
IBS QSYS implementation (Modules such as: APQP, FMEA, AUDIT, SPC ...)

Quality Management Systems Specialist Resume Examples & Samples

Administrator of the SpaceX stamp control process and system including procurement, inventory management, distribution, traceability and disposition of stamps across multiple organizations and sites
Use discretion and execute dynamic audits to assure system and process compliance in accordance with prescribed requirements and adherence to audit schedule
Administrative responsibility over external documents and web-based subscription service contracts including standards, specifications and technical papers required by the business. Status and maintain current specifications and post change announcements as required. Procure and fulfill request for various industry standards and specifications as new documents are required
Manage quality system data deliveries required by contract to customer portals, assuring on time delivery and contract compliance
Primary liaison between various functional groups and Management Systems to assure effectiveness, and timeliness of the corporate corrective action system
Consultative approach to problem solving to provide solutions and make independent judgements for process improvement
Ability to work independently with a strong work ethic, be innovative, detail oriented, possess initiative, be positive, and be people oriented
Highly motivated, quick thinking, and able to convey ideas and present unconventional solutions to unique problems
ASQ Certification (CQM, CQE, CQA, RAB), ISO/AS9100 certified / trained auditor
Proficient with Microsoft Office products, ERP databases and content management systems. Experience with Sharepoint and JIRA Confluence is preferred
Knowledge of aerospace, space and defense industry standards and specifications relative to design, production and management systems is preferred

IT Analyst Quality Management Systems Resume Examples & Samples

Under limited supervision, designs, specifies, implements, codes, tests and maintains automated and manual processes in support of business needs and/or corporate strategy
Works with customers to understand their business processes and IT needs while managing expectations within the boundaries of existing management directives
Elicits requirements for process improvement opportunities, coordinates process design or re-engineering efforts
Ability to translate and document business needs into functional requirements and technical designs
Executes projects utilizing internal project management methodology
Acts as liaison between implementation teams, process owners, and implementation sites
Builds and manages business cases to justify projects with defined scope
Provide support for complex business applications per defined SLA’s
Bachelor's Degree in Business/ Information Systems/ Computer Science with 2+ year related experience OR 5+ years’ experience in IT/IS as an Analyst or Developer
Experience with SAP/ Quality Management modules (Planning, Notifications, Inspections)
Broad knowledge of business process design, applications systems analysis, requirements elicitation, meeting facilitation, testing, support and project management
Knowledge of Agile or SDLC Methodologies
Experience/Knowledge with one or more of these ABAP, SQL , C++,C#, Java
Experience or knowledge of Oil and Gas Industry
Experience with other industry leading Quality Management Systems
Experience or knowledge of industry specifications for quality management systems like ISO 9001 or API Q2
Experience/ knowledge of developing, deploying and supporting multi-tiered business applications/ solutions
Experience/ Knowledge of document management technologies like SharePoint or Documentum
Excellent customer service, verbal, and written communication skills
May assume leadership role within a small group/project

Quality Management Systems Supervisor Resume Examples & Samples

QMS areas of ownership, management, and responsibility may include (as assigned): CAPA, Audit (internal, external, supplier), Post Market Surveillance (recalls / field actions, product risk review, post-market data review), Quality System Training, Document Control, Management Review, etc
Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility
Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective
Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes: generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance
Monitors the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards
Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections
Influences the organization in quality objectives, prioritization and resourcing decisions as necessary
Manages team of direct reports in support of the above (as applicable)
Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects
During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group
Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate
Minimum 5 years experience
Preferred minimum 7 years experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls
Minimum 2 years supervisory experience
Preferred training in FDA Quality System Regulation and ISO 13485
Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485)
Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, quality specialists, and management
Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication
Capability to interact with diplomacy and tact while maintaining appropriate assertiveness
Knowledge and use of relevant PC software applications and skills to use them effectively
Must be detail oriented, well organized and able to work independently and in teams