Head of QA/QE, Risk Management

Job TitleHead of QA/QE, Risk Management

Job Description

In this role, you have the opportunity to:

The Head of QA/QE, Risk Management develops organizational policies & standards and authorizes their implementation to ensure safe and reliable products, in compliance with regulatory requirements and Philips' Business Systems/procedures

You are responsible for:

  • Accountable for establishing a Process Quality Engineering practice in the area of Risk Management
  • Accountable for establishing the policies/standards of performance of the Process Quality Engineering work in scope including risk analyses, risk evaluation, risk mitigation plans and activities, risk control plans and risk files.
  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function. Viewed as an expert in the field and may be tasked with introducing new concepts. May have a leadership role.
  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
  • Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects
  • Expert knowledge of Risk Management Principles and practices including Safety Risk Management (ISO 14971), UFMEA and DMFEA

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 engineering degree, or equivalent experience.
  • Typically requires a Master's degree with > 10 years of related experience in a medical device or regulated industry
  • ASQ certification as Certified Quality Engineer or DfSS/DMAIC Green Belt / Black Belt.
  • Expert knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
  • Strong leadership skills and demonstrated ability to influence change and challenge status quo with respect to opportunities for improvement
  • Ability to manage competing priorities in a fast paced environment
  • Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
  • Advanced problem-solving, organizational, analytical and critical thinking skills
  • Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects
  • Proven expertise in statistical techniques
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
  • Identifies technical gaps and takes action to address them

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.

Contact

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