Philips QMS Manager in Andover, Massachusetts

Job Title: QMS Manager

In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

You are responsible for

  • Manages and maintains a compliant and effective QMS for the activities in scope (including, but not limited to addressing compliance deficiencies) as well as for effective and lean QMS structure and documents for Q&R processes in scope.

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies in scope are consistent with those regulations.

  • Ensures external and internal audit readiness and provides support during external and internal audits

  • Manages (local) Q&R processes in scope and ensures Q&R requirements are effective in all processes in scope.

  • Participates in Quality & Regulatory initiatives as a cross functional contributor

  • Creates PQMS awareness and establishes PQMS, owns all activities under the PQMS governance in scope and manages deployments.

  • Accountable to harmonize QMS processes in scope.

  • Establishes operational objectives and work plans, and delegates assignments to subordinates.

  • Establishes and assures adherence to schedules, work plans and performance requirements.

  • Manages 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. 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.

You will report directly to the Director of Philips Quality Management System & Customer Service.

Location: Andover, Cambridge

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

  • Bachelor’s degree. plus a minimum of 5 years of related experience in the medical device or another regulated industry

  • Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 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, ISO 14155, and ICH E6.

  • Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)

  • Legal and/or scientific background preferable

  • Demonstrates considerable knowledge of, and success with performing on, compliance-related projects

  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;

  • Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor

  • Attention to detail

  • Solid organizational and interpersonal skills

  • Ability to analyze information and come to conclusions based on presented data

  • Ability to communicate effectively both orally and in writing

  • Manage time working on multiple projects simultaneously

  • Open to other’s ideas and working collaboratively across functions and/or businesses

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

#LI-PH1

Job Title: QMS Manager

In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

You are responsible for

  • Manages and maintains a compliant and effective QMS for the activities in scope (including, but not limited to addressing compliance deficiencies) as well as for effective and lean QMS structure and documents for Q&R processes in scope.

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies in scope are consistent with those regulations.

  • Ensures external and internal audit readiness and provides support during external and internal audits

  • Manages (local) Q&R processes in scope and ensures Q&R requirements are effective in all processes in scope.

  • Participates in Quality & Regulatory initiatives as a cross functional contributor

  • Creates PQMS awareness and establishes PQMS, owns all activities under the PQMS governance in scope and manages deployments.

  • Accountable to harmonize QMS processes in scope.

  • Establishes operational objectives and work plans, and delegates assignments to subordinates.

  • Establishes and assures adherence to schedules, work plans and performance requirements.

  • Manages 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. 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.

You will report directly to the Director of Philips Quality Management System & Customer Service.

Location: Andover, Cambridge

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

  • Bachelor’s degree. plus a minimum of 5 years of related experience in the medical device or another regulated industry

  • Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 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, ISO 14155, and ICH E6.

  • Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)

  • Legal and/or scientific background preferable

  • Demonstrates considerable knowledge of, and success with performing on, compliance-related projects

  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;

  • Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor

  • Attention to detail

  • Solid organizational and interpersonal skills

  • Ability to analyze information and come to conclusions based on presented data

  • Ability to communicate effectively both orally and in writing

  • Manage time working on multiple projects simultaneously

  • Open to other’s ideas and working collaboratively across functions and/or businesses

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

#LI-PH1