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3.3 | Cambridge, MA | Hospital & Health Care | 10000+ Employees
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Posted 2 months ago on July 8, 2020

QMS Transformation Lead - Change Control

Full-time in Cambridge, MA
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Philips is a hospital & health care company headquartered in the Cambridge, MA area with 10000+ employees. Philips has a 3.3-star InHerSight Score, based on 1,197 ratings from 83 employees. 23 employees have left comments about their experience working for the company on InHerSight.

Job Title

QMS Transformation Lead - Change Control

Job Description

In this role, you have the opportunity to

Transform Philips QMS with the design and implementation of processes  for publication in the global quality system and ensure proper linkage with change processes and solution change processes.

You are responsible for

  • Work with the business process owner to design, establish and deploy standard requirements for change management on QMS content involving Quality, Regulatory and Clinical regulations and/or standards
  • Ensure requirements are universally applied such that Philips excellence change processes meet the minimum requirements
  • Coach business process owners who need to incorporate the change control standards into their  processes
  • Ensure output from change control processes are deployable to both legacy MS/QMSs and end state Aris Portals
  • Ensure output from change control processes meet Q&R auditing requirements
  • Build and maintain SME communicates in the Q&R domain to enable stakeholder participation in the design, development and deployment of PEPF change processes
  • Establish meaningful tracking and reporting on use/application of the QMS Change Control standard requirements across PEPF.
  • Design and implement the processes in Aris for publication in the global Aris system
  • Ensure output from the design is deployable to both legacy MS/QMSs and end state Aris Portals
  • Support and ensure successful deployments of processes used to establish and maintain MS/QMSs
  • Establish meaningful tracking and reporting on use/deployment of processes to drive standardization across Philips
  • Philips Excellence processes delivered must meet deployment readiness criteria
  • On time delivery of acceptable process deployment packages

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

  • Bachelor’s degree, preferably in a scientific discipline
  • 8+ years’ experience in establishing and maintaining regulated Quality Management Systems
  • Understanding of relationship requirements for MS, QMS and Legal Manufacturer to meet all Q&R regulatory expectations (including EUMDR)
  • Experience with delivering tools/methods for establishing QMS Quality Manuals and Intra-company Quality Agreements
  • Change Management – ability to influence stakeholders in the value and benefit of the new processes
  • Project management experience
  • Good communication skills written & verbal in English 
  • Demonstrated experience in collaborative working environments 
  • Experience addressing conflicts, escalation at team level to achieve desired results. 
  • Demonstrated experience handling deadlines, able to focus on targets 
  • Demonstrated experience-driving progress, taking initiative to achieve results. 
  • Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to delivering products & service to the customers.
  • Experience in leading process improvement methodologies
  • Demonstrated capability in organizational Change Management and stakeholder influencing

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.

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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