Quality Management Systems Resume Sample
Work Experience
- Develop, implement, and maintain a robust and productive Quality Management System across the enterprise
- Provide interpretation of regulatory guidelines and corporate requirements to ensure compliance and effective operation of the QMS
- Develop audit plans, and conduct internal audits to drive improvement and compliance across the business
- Communicate non-conformances as result of internal/external audits, and oversee the effectiveness of Corrective and Preventive Action plans
- Develop short- and long range plans to improve the effectiveness of QMS
- Conduct test plans for product testing (per QMS and/or regulatory requirements) through 3rd party lab, and develop corrective/preventive action plans to resolve any non-conformances
- Experience in various functions of quality, manufacturing and program/project management
- The ability to travel to our Western United States based manufacturing operations
- Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, CMO’s, vendors and investigator study sites
- Experience in the biopharmaceutical industry, of which at least 3-4 were spent in a Quality Assurance role
- Direct experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)
- In-depth understanding of current global regulatory expectations
- Accredited quality auditor is desirable
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
- Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
- Meet deadlines and multi-task efficiently
- Comfortable in a fast-paced environment with minimal direction and changing priorities
- Experience identifying changes, driving improvements and streamlining processes
- Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project
- Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
- 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
- Experienced in ISO 9001, ISO 13485 and ISO 14001 certification
Education
Professional Skills
- Excellent communication skills to build teams comprised of key skills, to drive progress to plan and to get management support and buy-in for complex projects
- Strong computer skills are required with good working knowledge of the MS Office Suite
- Conformity with quality regulations, standards, procedures, and successful audits. Demonstrates leadership skills
- Excellent skills for leading or facilitating multi-organizational teams to success on complex multidimensional projects
- Proven experience in managing quality management systems within a VET and higher education framework
- Demonstrated ability to effectively collaborate and partner with all levels of the organization, while maintaining an appropriate communication style
- Proven leadership ability and experience in leading multi-disciplined teams
How to write Quality Management Systems Resume
Quality Management Systems role is responsible for microsoft, liaison, communications, powerpoint, manufacturing, training, database, printing, security, planning.
To write great resume for quality management systems job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Management Systems Resume
The section contact information is important in your quality management systems resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality Management Systems Resume
The section work experience is an essential part of your quality management systems resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality management systems responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality management systems position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Management Systems resume experience can include:
- Leading the delivery of actions relating to the QMS, including documentation of control procedures, records management and recording of decisions and evidence
- Experience and knowledge in applying statistics, metrics, data analysis and reporting
- Proven relationship building ability with functional areas and internal customers, fostering an environment of trust and mutual respect
- Experience at executing quality audits and developing the quality management system
- Solid business acumen and a background enabling a detailed understanding of multi-functional business issues
- Process/Manufacturing experience in a printing or chemical process related field
Education on a Quality Management Systems Resume
Make sure to make education a priority on your quality management systems resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality management systems experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality Management Systems Resume
When listing skills on your quality management systems resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality management systems skills:
- Effective written and verbal communication and interpersonal skills to enable close liaison with production, engineering and QA staff
- Effective coordination & project management skills
- Strong math skills in statistics and probability
- Demonstrated work experience in managing a Quality Management System
- Demonstrated experience in providing operational advice to guide a range of stakeholders in a complex environment
- Proven AS9100 lead auditor experience at a mid-sized to large company
List of Typical Experience For a Quality Management Systems Resume
Experience For Quality Management Systems Specialist Resume
- Ensure that the Quality and Configuration Management systems are effective in meeting objections and certification standards
- Lead and/or Facilitate CAPA action requests from remedial action plans, root cause, corrective action, verification of effectiveness and through closure
- CMMI for Design and Development appraisal experience
- Knowledge and experience in the interpretation and application of Aerospace, Defense, and Industry Standards for Quality (e.g. AS9100, AS9102, Mil-Std-1520)
- Cooperate with various other Quaker departments and locations to build the Quality Culture within Quaker
- Providing a range of technical/specialist advice to stakeholders to ensure consistent application and understanding of the purpose and functions of the QMS
- Provide internal training for cross-functional continuous improvement projects and the subject matter expertise for QMS compliance and process improvements.
- Manages all external audits including third party certification, regulatory, government and customer audits
Experience For Project Manager, Quality Management Systems Resume
- Manage and co-ordinate Management Review Process and Quality Planning Review and Forums
- Develop and deliver training/compliance for Quality Management System group
- Liaise and lead conversations with notified bodies to manage certification changes. Represents the business during audits to discuss system functionality
- Develop/conduct quality-related training
- Assist process owners in developing meaningful metrics, root cause analysis for CARs, and implementation of corrective actions
- No paper tiger profile, but hands on mentality
Experience For Subject Matter Expert for Quality Management Systems Resume
- Availability to work in multinational and multicultural environment and to travel abroad for assigned missions
- Your personality is characterized by strong customer orientation, enthusiasm, high persuasiveness, results orientation, decision-making ability, organizational skills and quality orientation
- Proven experience in engineering, manufacturing, or software development, with an emphasis in the area of Quality Management System (QMS), including proactive Quality Planning and/or reactive Quality Systems
- Knowledge of Quality Management methods bases on norms and standards i.e. DIN ISO, APQP, FMEA, IP, SPC
- Provide support for complex business applications per defined SLA’s
Experience For Quality Management Systems Manager Resume
- 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
- Support QMS Director by driving CMMI initiatives and leading teams through the QMS
- Lead process improvement initiatives by utilizing existing infrastructure to maintain CMMI Level 5
- Facilitate development of advanced CMMI concepts to enhance QMS, business process, tools and measures
- Manage a portfolio of lean projects directed at reducing waste and improving quality to provide greater valve; implements such tools as: 5S, KPI, VSM, and Kaizen
- Drives the standardization of processes and the implementation of metrics and best practices
- Lead and/or facilitate internal and external audits (QMS, CMMI, AS9100, regulatory, customer, etc.)
Experience For Manager Quality Management Systems Resume
- Plans, manages and ensures completion of the internal audit program
- Ensures the promotion of customer focus throughout the organization
- Manages the corrective action process
- Manages the management review process
- Analyses nonconformance data trends and reports results to business area top management for consideration of improvement campaigns
- Gathers cost of quality data for the business area and reports to the corporate director of product assurance
- Assists and reviews statistical data collection, analysis, and presentation to illustrate product and process trends
- Works with functional management across the business area to ensure standardization of efforts and effective implementation of corporate and business area process and policy
Experience For Manager, Quality Management Systems Resume
- Develop and execute a QMS strategy that is aligned with the overall company, Manufacturing, Engineering, Marketing and Quality strategies
- Manage the Internal and External Audit processes. Setting the schedules, performing internal audits, and ensuring other auditors are trained
- Trains CAR assignees on root cause analysis techniques used during process and product nonconformance or failure investigations
- AS9100 / ISO 9001 Lead Auditor training
- Responsible for managing this area through cross-functional team members to complete agreed upon objectives
- Works with functional management to ensure business tools implemented meet applicable quality requirements
- Works with the business area product assurance organization to ensure delivered product conforms to established, company, regulatory standards and certifications
- Identifies and initiates corrective and preventive actions as necessary to maintain the integrity of the QMS
- Interfaces with customers to help understand SNC’s QMS and works with customers on any identified QMS issues
Experience For Quality Management Systems Supervisor Resume
- Leads or assists with projects as part of continuous improvement activities
- Analyzes risks and determines mitigation activities of the QMS system
- Good organizational and communication skills (written and oral). Ability to professionally interface and communicate with all division personnel, including executives
- Demonstrated use of analytical methods to research and investigate process improvement opportunities
- Proven ability to drive issues back to the source, root cause, or constraint
Experience For Quality Management Systems Coordinator Resume
- Expertise in a variety of root cause analysis techniques
- Ensure compliance to ISO 9001, 14001, and 13485 certifications for the Analytics and Automation business unit. Be the champion for our QMS and EMS systems, participating in efforts to ensure alignment across the company on a single quality philosophy and set of best practices
- Ensure our procedures are properly documented, managed, and practiced. Also, controls and measurements specified in our QMS are in place and drive process and quality improvements
- Form strong partnerships with Engineering, Product Marketing, Field Operations and the other Manufacturing departments
- Facilitate the Quality Management reviews ensure compliance and effectiveness to the standards
- Ensure that processes needed for the QMS are established, implemented, maintained, and audited to compliance and effectiveness
Experience For Project Manager Quality Management Systems Resume
- Experience with Quality in a high tech business
- Manage the Corrective and Preventive (CAPA) process
- Ensures clear, concise, accurate policies, procedures, instructions, forms, objectives are provided and maintained. Guide managers and directors in the correct implementation of the QMS
- Implement Continuous Improvement initiatives in terms of identifying, development, training of same
- Demonstrable knowledge of Quality in a manufacturing environment
- Initiate notification and/or escalation of emerging and signification risks to the relevant senior management and governance bodies, as appropriate
- Monitor and report on Key Performance Indicators (KPI's). Provide this information on a timely basis so that clear future strategy can be mapped and achieved
Experience For IT Analyst Quality Management Systems Resume
- Direct Quality performance as the company expands with the clear objective of "one standard for all"
- Demonstrable knowledge of Quality processes and tools
- Demonstrable knowledge of Quality Management Systems, in particular ISO 9001, ISO 13485
- Demonstrable knowledge of Environmental Management Systems ISO 14001
- Assess departmental policies and procedures, and propose changes that yield the best quality improvement return for the time and effort invested
- Train and mentor others in continuous process improvements
- Develop and Improve Micron’s Quality Management Systems
- Contribute to the creation and implementation of best practices to improve operational performance
- Implement all relevant procedures described in the Quality management system (QMS)
List of Typical Skills For a Quality Management Systems Resume
Skills For Quality Management Systems Specialist Resume
- Experience working in chemical manufacturing industry
- Preferably at least two years’ experience in a GMP pharmaceutical manufacturing environment
- People management experience in medical device manufacturing
- Experience managing a RA or QA department with 5+ years in Sr. Leadership role
- Preferably at least two years’ experience in a GMP manufacturing environment
- Experience in a quality or operations role in a multi-site manufacturing environment
Skills For Project Manager, Quality Management Systems Resume
- Previous experience managing a successful quality improvement process with multi-functional involvement
- Experience interfacing with internal customers, external customers, auditors
- Advance quality planning experience
- Experience working with ISO-9001, TS-16949, ISO-14001, ISO 18001
- Monitor the completion of tasks and ensure good performance and record on appropriate systems
- Experience in Automotive Quality Assurance Systems
Skills For Subject Matter Expert for Quality Management Systems Resume
- Consolidate Div.A external audits findings
- Good level of Italian and English required, both spoken and written
- Experience of Production processes improvement
- CMMI knowledge and experience is required
- Manufacturing quality management
- Working knowledge of quality-related software specific to Corrective Action, Audit Management, Training/Competency Management
- Support CAPA trending capabilities, enabling the identification of systemic root causes leading to the implementation of solutions to eliminate root causes
- Ensure POD business compliance with ISO 9001 standards- make recommendations to management on potential improvements and training opportunities
- Advanced quality tools including designed experiments
Skills For Quality Management Systems Manager Resume
- Demonstrable knowledge of Quality in a product development/engineering environment
- Support internal audit program by conducting IATF 16949 audits, gap analysis and corrective action implementation
- Provide strategic and tactical support of excursion reduction activities through improvement of systematic, error proofing activities and real-time detection
- Manage, coach and develop a high performing quality system team
- Develop CAPA centralized tools and process training
- Support ZF (Q-Academy & Div. A ) Training programs to ensure competency across the company
Skills For Manager Quality Management Systems Resume
- Provide coaching in GMP and Quality / GMP related SOPs
- Your way of working is characterized by a balance between speed and high level of accuracy
- Travel 10-25% of time across South China & Southeast Asia
- 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
- 17015 Aldine Westfield, Houston TX 77073
- Assist with the transition from ISO 9001:2008 to 9001:2015 standard
Skills For Manager, Quality Management Systems Resume
- Collaborate with Corporate Quality Group to promote alignment with Corporate Quality Manual
- Maintain POD Quality Manual, prepare updates and communicate within the business appropriately
- Primary POD contact for PolyOne’s external certification audits
- Conduct scheduled internal audits, collaborate within the business to address observations/non-conformances, and generate follow-up summaries for management team review
- Manage all aspects of onsite customer audits, including requests for supplier audits. Collaborate within the business to address finding and conduct improvements, prepare audit responses and generate follow-up summaries for management team review
- Tertiary qualifications and/or relevant experience in a related discipline such as Government administration, Planning, Governance, Project Management or Engineering
- Experience in developing, implementing or improving a Quality Management System (QMS) framework (ISO9001)
Skills For Quality Management Systems Supervisor Resume
- Experience with OEM specific quality requirements
- Experience in Quality Management area at an automotive industry
- CMMI appraisal experience is highly desired
- Experience in maintenance activities
- Knowledge of global GCP compliance regulations governing clinical development activities is required
- Experience with Responsible Care Management (RCMS), European Federation for Cosmetic Ingredients (EFfCI) and Round Table on Sustainable Palm Oil (RSPO) standards is highly desirable
- The ability to work with various manufacturing and corporate functions on both a regional and global level
- Proven competency in Control plans, D/PFMEA’s, QFD, Process Audits, ISO9001, & ISO/TS 16949, Key characteristic management, 8D/Corrective action skills, APQP, MSA, SPC, & PPAP
Skills For Quality Management Systems Coordinator Resume
- Commitment to the highest ethical standards and willingness to adhere to Faurecia’s Code of Ethics and Code of Management
- Expertise in ISO 9001, ISO/TS16949 and ISO13485 quality system standards
- In a quality or process improvement role
- ISO Lead Auditor Certification required
- Drive problem resolution to root cause
Skills For Project Manager Quality Management Systems Resume
- Working knowledge of Statistical Process Control (SPC), 8D problem solving, Kepner-Tregoe (KT) methodologies, FMEA/Control Plan, MSA, calibration, ESD, IATF 16949 and other quality methods and tools are required
- ASQ Certified in at least: Quality Auditor, Quality Engineer or ISO Lead Assessor
- Domestic & international travel
- Knowledge of EPA, OSHA Safety and PSM standards
- PMP, PRINCE2, Six Sigma, ASQ Quality Manager / Organizational Excellence
- 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
- Knowledge of health care operations, with a focus on quality management and care coordination services in acute and non-acute outpatient settings. Includes structure, department-specific policies and procedures and workflows
Skills For IT Analyst Quality Management Systems Resume
- A written response that clearly addresses the two targeted questions below (max. 2 x A4 pages), as this forms an essential component of your overall application
- Manage and lead site L3 and L4 quality audits and coordinating on CAPA completion of such audits
- Governance of site quality KPIs reporting activities
- Governance of CAPA, Quality Alert and Change Control process
- Manage and lead Site Quality Plan, Quality Risk Model activities
List of Typical Responsibilities For a Quality Management Systems Resume
Responsibilities For Quality Management Systems Specialist Resume
- Establishing, documenting, implementing and maintaining processes for the QMS
- Establishing and supporting the QMS steering committee to ensure customer requirements are met and evaluating accreditation options
- Designing, developing and implementing a Quality Management System (QMS) framework (ISO9001)
- Identifying, assessing and addressing non-conformance
- Managing the monitoring, measurement and evaluation of internal processes for change and improvement
- Evaluating and reporting on the performance of the QMS
- Promoting awareness of the QMS throughout the organisation and educating stakeholders
- Becoming knowledgeable in various Industry and Customer Quality System Requirements (ISO 9001, IATF 16949, AS9100, ISO 13485, ISO 22000 & 21469)
- Ensuring adherence to all Industry and Customer Quality System requirements as necessary
Responsibilities For Project Manager, Quality Management Systems Resume
- Handling third party and client quality audits
- Developing and maintaining project specific QEHS systems on major projects per applicable client requirements
- Developing specifications for proposed solutions to address the internal clients’ or users’ needs
- Assists in developing and writing documents (Standard Operating Procedures, Quality Manuals, Work Instructions)
- Identify improvements and inputs into the quality planning process
- Conducts Quality Assurance orientation and various training programs for new hires and other associates
Responsibilities For Subject Matter Expert for Quality Management Systems Resume
- Reports on the status of CARs and follows up on outstanding actions
- Assistance to other corporate services teams by providing AMS related inputs and guidance
- Delivery of AMS-related training to different staff levels and roles
- Management of corrections and corrective actions arising from internal and external audits, user feedback and other sources
- Semiconductor backend manufacturing
- Corrective Action Tracking
- Ensure all necessary systems and procedures are in place to satisfy all IATF 16949 and customer requirements
- Support IATF 16949 certification efforts
Responsibilities For Quality Management Systems Manager Resume
- Manage all external registration requirements to ensure they are met. Liaise with external bodies on all matters relating to registration. Maintain and improve, in line with business needs
- Based upon the overall Quality System performance, identify critical systems or processes where additional control points and quality improvements are required, initiate projects or activities to analyze, evaluate and propose solutions to address the problem and improve performance
- Facilitate the management review process
- Collaborate with cross functional groups for the implementation and enhancement of process control systems
- Identify, drive and implement continual improvement projects in area of process control by applying the relevant control mechanism. Manage and monitor projects to ensure target deliverables and time frames are met
- Work with subject matter experts internally and externally to identify business process gaps and Best Known Methods (BKMs) to address
- Provide support to site quality director on other responsibilities and ad-hoc activities
- Motivate and coach the team to operational success
- Consistently promote high standards of performance
Responsibilities For Manager Quality Management Systems Resume
- Hold individual accountable of the results
- Liaise with key business partners to develop alignment and collaboration in GxP CAPA process oversight
- Manage an independent escalation method to support global GxP CAPA governance, and support the escalation of individual CAPAs at risk and/or negative trends in Key Performance Indicators
- Support interactions with key senior leaders to maintain executive awareness of GxP CAPA performance
- Plan, execute and deliver CAPA strategies/plans for the remediation, correction and prevention of recurrence of those significant quality events with broader impact across the Janssen R&D QMS
Responsibilities For Manager, Quality Management Systems Resume
- Support investigation of large scale significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate
- Manage defined thresholds enabling the tracking/trending of escalated issues across the QMS holistically inclusive of CAPA escalations to leadership councils or forums
- Establish accurate and actionable metrics to identify areas of risk, performance to commitments, effectiveness and timeliness of GxP CAPAs
- Support Regulatory Inspection readiness initiatives and activities across GxP disciplines/segments, as appropriate
- Manage CAPA system/process to eliminate the causes of detected discrepancies (reactive), and preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive)
- Collaborate with five other functions (Quality Planning & Strategy, Quality Analytics, Quality Management, Quality Assurance, and Janssen Diagnostics Quality) and other quality groups through governance to support identification of risks within quality and compliance and implement appropriate mitigation actions across the R&D QMS
- Support BRQC/Janssen CAPA forums or equivalent to ensure oversight of CAPA measures
Responsibilities For Quality Management Systems Supervisor Resume
- Maintain appropriate level of expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs and unit/project-specific procedures within Janssen applicable to the processes and systems within the scope of the R&D QMS
- Support key business partners and stakeholders to liaise between quality groups, and governance to enable and promote quality, accountability and quality culture
- Specific items this person would be doing at that facility or for the specific role
- Manage ISO 9001 and API Q1 Quality Manuals and programs at the corporate quality level
- Interface with API for licensed facilities and ISO Registrar for ISO registered facilities
- Perform critical supplier quality audits
- Manage Corrective Action System
Responsibilities For Quality Management Systems Coordinator Resume
- Provide quality data and quality assurance reports to senior management, as required
- Ensure the Quality Management System is in compliance with the appropriate internal & external regulatory requirements
- Develop optimum future state of Quality Management System for business need, aligned with Corporate Quality Management System
- Be a key driver of GMP and GDP practices within Quality
- Contribute to the development, maintenance and improvements of the policies and procedures
- Implement best in class practices and benchmark against industry leads and regulatory requirements
- Provide direction on QA strategy for the overall Project group of assigned projects. Execute and oversee the Project Quality Plan of assigned projects. Proficiency in leading improvement processes, executing and leading projects, understands project stages
- Has knowledge of how system functionality supports the business requirements in their business area
Responsibilities For Project Manager Quality Management Systems Resume
- Has understanding of the IT system validation documents for which the business has ownership, input or approval requirements (e.g. System Description, Project Management Plan, Testing Strategy, Test Summary Report, Requirements, Traceability Matrix, Validation Summary Report)
- Fostering and promoting professional and consistent work practices across TAFE NSW by ensuring the educational QMS is current, accessible and continuously improving
- Providing a range of technical/ specialist advice to stakeholders to ensure consistent application and understanding of the purpose and functions of the QMS
- Providing operational guidance and advice to ensure business process owners understand how the QMS supports compliance and quality particularly those related to AQSA and TEQSA requirements
- Engaging with business owners to identify critical business needs and requirements to ensure quality information and written directions (policy, procedures etc.) in a changing environment
- Proven experience in managing quality management systems within a Vocational Education Training and Higher Education framework
- Strong knowledge of AIAG Core Tools (APQP, PPAP, FMEA, MSA, SPC)
- Have at least 7 years of experience in related areas of responsibilities (project management, operations etc.)
Responsibilities For IT Analyst Quality Management Systems Resume
- Support the North America Quality Management System (QMS), its policies and programs. This includes
- Document and drive for continuous improvement
- Document and implement preventative actions
- Supports the ISO QMS program with external audit registrar
- Attends audits and management review meetings, conduct 1st party audits
- Support management of the document control program
- Assists and coordinates Quaker’s QMS Internal Audit process
- Develops annual internal audit schedule
- Schedules annual internal audits at Quaker facilities with Quaker quality internal auditors, site management, and site representative