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Philips Q&R Leader in United States of America - Home Based, Massachusetts

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Q&R Leader

In this role, you have the opportunity to

Play a key role in a fast-growing Philips venture, disrupt a billion dollar industry and touch millions of lives by developing a unique medical device solution. Your challenge will be to guide and support the EPD Solutions team to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

As a Q&R Director you will have the challenge of ensuring the QMS is in full compliance with all applicable regulatory requirements.

You are responsible for

  • Developing, promoting and communicating the Quality Policy, Quality Objectives and Quality Strategy throughout the EPD Solutions organization.

  • Being a member of, and advising the EPD Management Team on quality and regulatory strategies, potential areas of concern and new governmental/regulatory developments.

  • Managing EPD Solutions wide Q&R staff to ensure the effective and efficient use of department resources and continuous process harmonization and improvement at each site.

  • Providing ongoing guidance, training and development to the staff.

  • Reviewing, approving and ensuring the implementation of EPD QMS procedures at each site. Driving continuous improvement of the implemented Quality System. Ensuring EPD Solutions is in full compliance with all applicable requirements.

  • Providing strategic development and support of the EPD product submission strategy to ensure that global business objectives are fully met.

  • Maintaining strong relationships with regulatory agencies, competent authorities and standards organizations which impact EPD Solutions. Representing EPD solutions at all external audits and inspections including FDA, Notified Body and all other third-party audits.

You are a part of

Philips EPD Solutions, a recently acquired venture with ambitious plans for growth, developing a disruptive technology, which will improve the efficiency and efficacy of life-saving cardiac ablation procedures treating among others atrial fibrillation. Over 33 million people worldwide suffer from atrial fibrillation, its management costing $26 billion per year in the US alone. Currently, up to half of all cardiac ablation procedures need to be repeated due to incomplete ablation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease. Having obtained CE mark in 2018, we are preparing for a commercial product launch in Europe, US and other territories and are seeking regulatory approvals around the world.

As a Q&R Director you will have the challenge of ensuring the QMS is in full compliance with all applicable regulatory requirements. It is a global role, with a primary focus on Quality for EPD Research in Israel.

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

  • Bachelor of Science degree (B.Sc) in biological sciences, engineering or equivalent

  • 15+ years of progressive experience managing a Quality & Regulatory department within the medical device industry or leading SW development with solid background in medical device regulations

  • Proven track record in maturing ventures into an established business

  • Successful track record with U.S. FDA inspections and Notified Body assessments

  • Successful track record of obtaining global product approvals in the healthcare software and medical device industry

  • Strong understanding of global Quality System requirements as they apply to the medical device industry

  • Demonstrated ability to lead and influence teams and individuals globally

  • Willingness to travel 50% globally

  • Excellent communication skills in English

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.

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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