Head of Quality Management Systems & Customer Service - BG Monitoring, Analytics & Therapeutic Care

Job Title

Head of Quality Management Systems & Customer Service - BG Monitoring, Analytics & Therapeutic Care

Job Description

We challenge you to ensure compliance and effective quality management systems (QMS) are maintained in scope; as well as, provide accountability for a QMS transformation towards a single Philips Quality Management System (PQMS) structure. Additionally, you will deliver on the management of and harmonization of all current QMS within BG Monitoring, Analytics & Therapeutic Care (MA&TC).

This leader will guide and develop a team across multiple locations to effectively maintain (local) Q&R processes and (local) process ownership for all activities under the PQMS governance remain in scope. We want you to be accountable for leading and harmonizing all QMS management processes, and ensuring the FDA-compliance validation of all software systems.

You will be responsible for certifying all process requirements for Q&R, document control are established and effective; and training profiles are assigned, implemented and administered.

In this role, you have the opportunity to

  • Play a key quality & regulatory role within Philips to guide and support Business Groups, Markets and enabling functions to-always-do the right thing.
  • Be a confident advisor on approval, regulatory compliance, and quality management related topics, in order to achieve timely releases of products to deliver high quality and excellent reliability to the lives they will improve.
  • Independently review and approve completion, compliance, and audit ability with QMS requirements at project landmarks (e.g., quality gates) throughout the total product lifecycle.
  • Lead all of the activities of BG PQMS team including contract resources; and will formulate the long-term QMS framework for the business to ensure full compliance to PQMS content and structure.

You are responsible for (but not limited to)
  • Successfully guiding and handling Philips relationships with regulatory agencies; such as the US Food and Drug Administration (FDA).
  • Exercising supervision in terms of costs, methods, and staffing.
  • Establishing and assuring adherence to budgets, schedules, work plans, and performance requirements. Typically leads subordinate Team Leaders.
  • Being involved in developing, deploying, and improving company policies and procedures that affect immediate operations.
  • Working on issues where analysis of situations or data requires an in-depth knowledge of business objectives.
  • Ensuring all released products, align with all the significant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.
  • Regularly interacting with senior management or executive levels on matters concerning several functional areas and/or customers.
  • Driving transformation across the business group; as well as, being a change agent for transformation.

You are a part of a team

As a result of Philips renewed dedication and commitment to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership and can harness the expertise of five Centers of Excellence (COE). These five (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 and significant impact on your team, our business, and health technologies to improve the health, well-being and care for people around the world.

This Andover-based role will be within the Q&R organization supporting QMS and Customer Service for BG MA & TC.

To succeed in this role, you should have the following skills and experience
  • BA/BS degree is required; Masters' degree preferred.
  • 10+ years of Quality Management Systems experience working in a focused regulated industry (automotive, aerospace, medical device, pharma), required; Medical Device industry highly preferred.
  • 8+ years' experience leading people and leading teams across multiple sites globally and delivering on business objectives; as well as, to deliver business application implementation projects, including experience as an active contributor on scheduled projects, required
  • Experience in the application of Industry standards for Q&R including ISO 9001, ISO 13485, ISO 14001, required
  • Robust communication, leadership and influencing skills to enable effective implementation and execution, required
  • Experience in a large multinational with global exposure, required
  • Knowledge of Regulatory Affairs responsibilities, product development, factory and supply chain experience, highly recommended
  • Validated analytical skills, with the ability to troubleshoot complex process/system issues
  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions

In return, we offer you

We offer you a dynamic working environment in an innovative business, which offers you excellent opportunities to further develop and fully exploit your talents. This job comes with a competitive salary, excellent benefits, and up-to-date training.

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 .

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, and 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.

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Contact

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