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In this role you will have the opportunity to make a substantial contribution to the development of the Philips Ultrasound Quality Management System. The Sr. QMS Project Leader is a key role needed to ensure Ultrasounds’ QMS standardization to the Philips Excellence Process Framework (PEPF).

You are responsible for

• Supporting the Philips Quality Management System Transformation by fulfilling an Ultrasound PQMS leadership role for QMS Standardization and consolidation efforts

• Maintaining the Ultrasound 3rd Party Audit program including:◦Serving as audit host and/or backroom lead

• Leading readiness activities

• Leading and implementing FDA state of readiness

• Training SMEs on how to conduct themselves during audits

• Facilitating audit finding investigations and development of action plans

• Leading quality and regulatory compliance projects to maintain compliance and adapt the QMS to the continuously evolving external regulatory environment

• Contributing to the development and execution of the Ultrasound QMS strategies for regulatory compliance and improvement

You are a part of the Philips Ultrasound Team. Our mission is to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Our QMS is an enabler for this mission.

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

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

• A minimum of a Bachelor's Degree in a Science/Engineering or other relevant technical discipline (Masters Degree preferred)

• 10+ years of experience working in quality or regulatory at a medical device design/manufacturer

• Strong knowledge and understanding of global Medical Device standards and regulations including FDA QSR and ISO13485:2016

• 5+ years’ experience with regulatory audits – either as Front Room or Back Room lead

• Experience leading QMS projects

• Experience writing Quality Agreements

• Certified Lead Auditor experience preferred

• Ability to interact professionally with all organizational levels

• Must be results-driven - able to manage competing priorities in a fast-paced environment

• Ability to communicate ideas and information clearly, effectively and concisely

• Highly detailed oriented with strong organization and prioritization skills

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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