Philips FCO Program manager in Andover, Massachusetts

FCO Program 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.

Your Responsibilities :

  • Project management of FCO after launch. This involves close interaction with Philips servicing and Q&R markets functional management to manage/track regulatory closure of PCMS FCOs.

  • Accurate and on time tracking of open PCMS field actions on a monthly basis

  • Support Post market surveillance group with Competent Authority requests

  • Working with all PCMS businesses to tracking and archiving non-reportable Field Action Decision forms

  • Collaborate with PCMS businesses and Philip’s key market representatives to accurately track and document field corrective actions

  • Work with vendor(s) to provide accurate customer mailing tracking data that meets regulatory requirements

  • Support external and internal audit of the reporting group when needed.

  • Perform other duties as assigned

Your Profile

  • BS in technical discipline or equivalent education, experience, training

  • Project Management skills are desired

  • At least 3 years of Quality and/or Regulatory experience in a medically regulated and technical environment

  • A understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 (Recalls, Corrections and Removals)

  • Demonstrated strong organization skills

  • Proficiency using Philip’s tools (Trackwise, SAP),

  • Proficiency in Microsoft Excel is required.

  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements.

  • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.

  • Requires the proven ability to consistently meet and/or exceed goals.

  • Must be capable of making commitments, setting priorities, and delivering results on time.

  • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.

In return, we offer you

A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 .

Find out more info about Philips at www.philips.com/na/careers

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.

FCO Program 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.

Your Responsibilities :

  • Project management of FCO after launch. This involves close interaction with Philips servicing and Q&R markets functional management to manage/track regulatory closure of PCMS FCOs.

  • Accurate and on time tracking of open PCMS field actions on a monthly basis

  • Support Post market surveillance group with Competent Authority requests

  • Working with all PCMS businesses to tracking and archiving non-reportable Field Action Decision forms

  • Collaborate with PCMS businesses and Philip’s key market representatives to accurately track and document field corrective actions

  • Work with vendor(s) to provide accurate customer mailing tracking data that meets regulatory requirements

  • Support external and internal audit of the reporting group when needed.

  • Perform other duties as assigned

Your Profile

  • BS in technical discipline or equivalent education, experience, training

  • Project Management skills are desired

  • At least 3 years of Quality and/or Regulatory experience in a medically regulated and technical environment

  • A understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 (Recalls, Corrections and Removals)

  • Demonstrated strong organization skills

  • Proficiency using Philip’s tools (Trackwise, SAP),

  • Proficiency in Microsoft Excel is required.

  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements.

  • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.

  • Requires the proven ability to consistently meet and/or exceed goals.

  • Must be capable of making commitments, setting priorities, and delivering results on time.

  • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.

In return, we offer you

A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 .

Find out more info about Philips at www.philips.com/na/careers

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.