Philips Quality Management System(QMS) Software Engineer in Andover, Massachusetts

Primary Responsibilities include:

1) Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages of IT applications in a regulated industry.

2) Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Philips in appropriate verification and validation testing requirements.

3) Support Business Groups and Markets’ Quality & Regulatory Validation groups in following the established process and procedures for Validation in Philips.

4) Provide guidance/feedback to IT applications group in Validation compliance as per the applicable regulatory requirements and Philips policies and procedures.

5) Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.

6) Create and revise departmental procedures and other documentation to support the Quality System in regards to validation compliance.

7) Participate in corrective and preventive actions (CAPAs) to improve the validation practices.

8) Provide practical solutions to a wide range of difficult challenges in IT validation independently.

9) Work independently to determine and develop solutions that are innovative, thorough, and practical.

10) Support the internal/external audits and regulatory inspections from a validation perspective.

Skills:

Bachelor’s degree in engineering or IT related fields, preferred; advanced degrees are preferable in Quality, Regulatory or Software Engineering.

5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.

5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).

Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.

Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.

In this role, you have the opportunity to

To support ongoing Software Validation Program responsibilities under PQMS (Philips Quality Management System) Software Management Center of Excellence in order to meet regulatory requirements in the validation of IT applications.

You are responsible for

  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages of IT applications in a regulated industry.

  • Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Philips in appropriate verification and validation testing requirements.

  • Support Business Groups and Markets’ Quality & Regulatory Validation groups in following the established process and procedures for Validation in Philips.

  • Provide guidance/feedback to IT applications group in Validation compliance as per the applicable regulatory requirements and Philips policies and procedures.

  • Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.

  • Create and revise departmental procedures and other documentation to support the Quality System in regards to validation compliance.

  • Participate in corrective and preventive actions (CAPAs) to improve the validation practices.

  • Provide practical solutions to a wide range of difficult challenges in IT validation independently.

  • Work independently to determine and develop solutions that are innovative, thorough, and practical.

  • Support the internal/external audits and regulatory inspections from a validation perspective.

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

  • Bachelor’s degree in engineering or IT related fields, preferred; advanced degrees are preferable in Quality, Regulatory or Software Engineering.

  • 5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.

  • 5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).

  • Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.

  • Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.

In return, we offer you

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

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.

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.