Director Of Quality - Qms/Compliance

Philips Monroeville , PA 15146

Posted 2 months ago

Job Title

Director of Quality - QMS/Compliance

Job Description

In this role, you will lead PQMS teams and programs to ensure the highest level of compliance, effectiveness and efficiency.

You are responsible for

  • Direct, lead, and develop the Sleep & Respiratory Care team in a manner aligned with the Philips PQMS function.

  • Identify, track, and plan for continuous improvement of the critical metrics associated with the PQMS enabling function.

  • Lead all aspects of the QMS functions for QMS Management (Document Control, QMS Software Validation, Training Administration), including CAPA, Management Review, and Quality Planning processes. Provide audit support for internal and external audits.

  • Participate in building, deploying, managing, and continuously improving the associated processes in the PEPF to ensure that it is compliant, effective, and efficient.

  • Sustain the SRC quality management systems to ensure continued compliance with regulations and standards by focusing on areas of responsibility identified for the PQMS function.

You are part of

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

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.

To succeed, you should have the following skills and experience

  • Bachelor's degree, preferably in a life-scientific discipline, and a minimum of 12 years of experience working in the Medical Device Industry and at least 7 years in a leadership role. Master's degree preferred.

  • Confirmed leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to improve product market access.

  • Q&R Functional experience.

  • Confirmed experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.

  • Technical experience with systems used to automate quality system processes.

  • Strong understanding of Quality System Regulations ISO 9001, ISO 13485, 21 CFR Parts 803,806 and 820.

  • Ability to work closely with senior management.

  • Confirmed ability to take independent action for process improvement.

We offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you seek. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to build your own legacy.

Why should you join Philips?

This is more than a job. It's a calling to create a healthier society through meaningful work, passionate about 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.

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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Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.

If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to careersite@philips.com.

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)


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Philips Monroeville PA

Director Of Quality - Qms/Compliance

Philips