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3.3 | Cambridge, MA | Hospital & Health Care | 10000+ Employees
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Posted a week ago on June 29, 2020

Head of PQMS, HRC

Full-time in Carlsbad, CA
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Philips is a hospital & health care company headquartered in the Cambridge, MA area with 10000+ employees. Philips has a 3.3-star InHerSight Score, based on 1,197 ratings from 83 employees. 23 employees have left comments about their experience working for the company on InHerSight.

Job Title

Head of PQMS, HRC

Job Description

In this role, you have the opportunity to

Lead the PQMS (Philips Quality Management System) Group and develop, implement, and maintain the Quality Management systems to ensure compliant and effective QMS is maintained and in scope.

You are responsible for

  • Manage, lead, mentor and direct the activities and performance of the PQMS team consisting of QMS and Document control team members and develop a world class PQMS team.
  • Manage the PQMS processes and ensure process ownership for all activities under the PQMS GOVERNANCE IN SCOPE.
  • Accountable to manage and harmonize QMS processes and ensure the FDA and international compliance.
  • Ensure Document Control is established and ensure training profiles are assigned and enforced and training administration is established within scope.
  • Guide the business and enabling functions to always do the right thing, the first time. This involves being confident with your knowledge and effectively influencing others.
  • Lead the Document, Change and Records Control systems for the business, driving continuous improvement in support of the business processes and objectives
  • Maintain, enforce and manage a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.
  • Establish and execute quality transition plans for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS
  • Support the timely deployment of Philips Quality Management System (PQMS) and PIL solutions.
  • Implement and manage the QMS Audit Program to ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
  • Assist in achieving continued Quality System Certification by supporting both internal and regulatory agency audits; including coordinating, participating in, and conducting audits as needed. This may include, but is not limited to, quality system/ product audits.
  • Manage the training system, ensuring training requirements are established, implemented and maintained for the business.
  • Support the CAPA Program, and perform timely and detailed CAPA tasks including assessing problem descriptions, CAPA investigation, assisting with root cause analysis, and quality problem solving as appropriate
  • Ensure quality system documents and records adhere to Good Documentation Practices (GDP) compliance.
  • Participate in the improvement of quality system processes, documentation practices, and training.

You are a part of

The Philips Hospital Respiratory Care business products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.   We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree plus a minimum of 8+ years of related experience in the medical device or another regulated industry.
  • Advanced 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. Active Lead Auditor Credentials preferred.
  • Understanding of the Medical Device Single Audit Program (MDSAP)
  • Experienced Leading with shown success leading teams and delivering on organizational objectives
  • Validated 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 efficiently 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, detailing findings/actions, and implementing actions.
  • Advanced Analytical Skills; confirmed ability to troubleshoot complex process/system issues
  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
  • Executive interpersonal communication skills; ability to prioritize and lead multiple simultaneous programs/projects

In return, we offer you

The opportunity to be part of an organization that is committed to touching 3 billion lives worldwide.  The opportunity to use your data analytic skills to support products that provide lifesaving diagnostics and therapy.  A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.

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.

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.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws.  Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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.



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