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Philips Director, Quality & Regulatory in Gainesville, Florida


Director, Quality & Regulatory

In this role you will be responsible for ensuring business continuity while building the new working model for our RFRC business.

You are responsible for

  • Crafting, developing, and implementing a new working model for the RFRC business as part of project Wolf (i.e. legal manufacturer design, delegations, oversight models, and footprint required to ensure sustainable execution).

  • Establishing and owning the Q&R Wolf Governance model:

  • Leading, in partnership with Pune (India), the Business Quality actions related to project Wolf, while ensuring that other matrixed quality functions have clarity in their scope of accountability and deliver on their commitments.

  • Driving resolution to project related issues, ensuring appropriate communication structure is in place with partners.

  • In parallel to project Wolf, this role will also represent Imaging Components in strategy development, decision making, and ensuring execution related to the business split between Imaging Components and DMS.

  • Effectively handling interdependencies between Wolf, the DMS split, and EU MDR

  • Enabling the vision for the Imaging Components Q&R team.

  • Influencing business partners and encouraging the organization to ensure the EU MDR committed timeline is met/exceeded.

  • Acting as site management representative for all key regulatory agencies for product safety and quality.

  • Actively ensuring the Gainesville RFRC business is in a constant state of audit readiness.

  • Leading and driving effective deployment of the Philips Excellence Process Framework and Quality Management System

  • Providing leadership and direction to the Q&R organization in support of the RFRC business (part of Imaging Components Business Category).

  • Implementing an effective local governance structure that drives accountability, ensures detailed execution, and drives rapid issue resolution to enable compliant business performance.

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

  • Bachelor’s, Master’s, or PhD in a technical discipline.

  • 10+ years of regulated industry experience

  • Business sense and strong business partnering skills

  • Effective communicator and relation builder/networker

  • Willing to travel up to 25%

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

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, #5, for assistance.