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Philips PQMS Manager in Cambridge, Massachusetts

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

In this role you have the opportunity to

In this role you will have the opportunity to Ensure compliant and effective QMS’s are established in ISC factory sites.Ensures Q&R requirements for production & process controls are effective in ISC factory QMS's, as well as for other processes where applicable.

You will part of a team of QMS Managers & specialists who assist ISC Factory site Quality Leaders / QMS Managers in maintaining their QMS compliance. To do so, you will represent ISC in various meeting and interact with the central Quality organization.

Your role:

  • Support ISC factory QMS's in developing/ maintaining their QMS in compliance with Quality & regulatory requirements.

  • Maintain, enforce, and manage a compliant and effective QMS for the activities in scope of ISC factory sites, as well as for effective QMS structures and documents for QMS processes.

  • Manage the transition/deployment of the QMS framework into the ISC local QMS’s.

  • Be the liaison for global QMS initiatives led by the central quality organization and the ISC Factory quality organization.

  • Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations. Support Audit preparation and follow-up as appropriate.

  • Support local transition plans for all QMS parts in scope of a transition/deployment while maintaining compliance and effectiveness throughout the duration. Support process improvements/harmonization across ISC QMS's.

You're the right fit if:

  • Bachelor or Master’s degree (preference of engineering or medical technology) or professionals with equivalent qualifications.

  • 10+ years of quality and regulatory experience in a medical device company on international level.

  • Experience in quality system management compliant with ISO 9001 and ISO 13485 standards, EU MDR and 21 CFR part 820 regulation.

  • Experience in participation into global program within multinational environment. Experience in managing Production and Process Controls in a factory environment.

  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remoteposition.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business.

  • Discover our rich and exciting history.

  • Learn more about our purpose.

  • Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $77,000 to $135,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

#LI-PHI

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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