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Philips Director of Quality in Bothell, Washington

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Director of Quality

In this role you have the opportunity to provide strategic direction and leadership regarding all aspects of Quality and Regulatory areas to the Connected Care Informatics (CCI) business Q&R teams and various sites located globally. The leader is a driving strength in making the Connected Care Cluster Q&R an industry leading organization through improved customer experience, dedicated regulatory compliance across FDA Class I and II medical devices and various global competent authorities and dedicated quality excellence. Some of the key quality activities related to this role are product design and sustaining & improvement, initial supplier selection and qualification including APQP, merger and acquisitions, post market surveillance, product registrations, customer service, procurement, business focused distribution centers, and management of various elements of a well-defined Quality Management Systems and quality key performance indicators assuring business quality & compliance.

  • The position reports solid line to the Head of Q&R for the Connected Care Cluster and dotted line to the Business Leader and will be a key member of the Quality Management Team representing quality and regulatory functions.

  • Position requires an inventive and a strategic thinker who will work to provide results-oriented leadership and creativity required to own an effective and hardworking Q&R organization and teaming closely with business leaders to maintain a robust and efficient Quality Management System and behavior that will be accepted by our customers and regulators as best in class. The quality leader will work closely with business partners and various business Q&R leaders to drive standardization of key processes including product quality initiatives.

  • Travel about 50% of the time for the first six months and thereafter dropping to 25%.

Responsibilities

  • Identify and implement standard methodologies to improve efficiency and maintain compliance and lead the function in continuous process improvement.

  • You will lead a team of Q&R professionals responsible for 5 business categories as follows: Electronic Medical Records (EMR), Patient Care Analytics (PCA), Clinical Command Center (CLOC), IntelliSpace Enterprise Edition (ISEE), and Enterprise Integrated Solutions (EIS) / IntelliBridge Enterprise (IBE)

  • Ensures that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products; thus, must have good knowledge of worldwide regulations.

  • Represent the business during any audit, internal or external. Drive compliance across all functions of the business and ensure preparedness for any audits. Take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.

  • Works with quality and regulatory leaders across the corporation to identify and implement standard methodologies.

  • Maintains productive working relationships with external regulatory bodies.

  • Implements appropriate activities to ensure regulatory compliance and adherence effectiveness of the quality system such as: complaint handling, corrective and preventive action, and the internal audit program.

  • Monitors external changes to the regulatory environment to ensure the continued compliance of the quality system.

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your business have clear collaboration 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, Risk Management, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this 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 (Science, Engineering or similar technical discipline) required, Master's degree in business, management or quality strongly preferred

  • Minimum 10+ years working experience of which a couple of years dynamic management experience in a responsible Quality Assurance/Regulatory Affairs role (required)

  • Having led a larger team in a global setting (required)

  • Experience in Quality Systems and in Regulatory Affairs (required)

  • Experience in Software development and products is required

  • Medical Device experience (preferred) or automotive, aerospace, defense experience is required

  • Strong partner management skills

  • Experience with FDA and other worldwide standards and regulations is preferred

  • Achievement oriented and customer focused

  • Open to Travel about 50% of the time (after the first year this will be less)

In return, we offer you

  • A challenging, innovative environment with outstanding opportunities for you to explore.

  • Our benefits are very high-reaching and designed around your preferences:

  • A market conform salary

  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

  • Proven company pension scheme and attractive collective health insurance package

  • Opportunity to buy Philips shares and products with discount

  • Healthy work-life balance

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,, for assistance.

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