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Job Title QMS Engineer

Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).

You are responsible for

  • Ensures training program compliance and timely training execution
  • Ensures external and internal audit readiness and provides support during external and internal audits
  • Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus standard requirements
  • Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
  • Represents QMS/Engineering Change processes and records to regulatory agencies as required
  • Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
  • Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities
  • Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
  • Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
  • Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
  • Supports the move toward the Philips Excellence Process Framework for the transformation the business to the Philips Business System including the Philips Integrated IT Landscape
  • Promoting Q&R awareness level as determined within the organization
  • Managing the enforcement of standardized quality systems across the Business; ensuring deployment of strategic projects & E2E PIL Solutions to schedule
  • Establishes an effective Management Review process, including routine reporting
  • Managing the strategic improvement processes ('breakthrough Program') in the Business (One Page Strategy, Hoshin Plan)
  • Participates in Quality & Regulatory initiatives as a cross functional contributor
  • Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance
  • Establishes operational objectives and work plans, and delegates assignments to subordinates
  • Establishes and assures adherence to schedules, work plans and performance requirements
  • May manage or oversee individual contributors

You are a part of

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

To succeed in this role, you should have the following skills and experience
  • Bachelor's degree plus a minimum of 2 years of related experience in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
  • Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA's 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
  • Experienced Engineer with proven success within teams and delivering on organizational objectives
  • Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
  • An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
  • Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
  • Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
  • Strong IT Skills
  • Ability to travel up to 25%
  • Position to be strategically located at the Pittsburgh CoE

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That's okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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