CT/AMI R&D Design Controls Leader (SG70)

Job TitleCT/AMI R&D Design Controls Leader (SG70)

Job Description

In this role, you have the opportunity to

The Computed Tomography/Advanced Molecular Imaging Research and Development (CT/AMI R&D) Design Controls Leader is the process owner for Design Controls and Risk Management related SOPs, WI, and templates. The CT/AMI R&D Design Controls Leader will work hand in hand with Q&R to ensure the design controls processes are compliant, and the quality records produced by those processes are also compliant. CT/AMI R&D Design Controls Leader will also be responsible to tracking major regulatory changes and ensuring compliance to ongoing changes.

You are responsible for

Key Areas of Responsibility:

  • Work with Q&R to establish and maintain a compliant design controls and risk management process.
  • Monitor the regulatory landscape, establish compliance roadmaps, and ensure adequate plans are in place to address ongoing regulatory changes.
  • Own, track, and drive QMS Operationalization activities within R&D
  • Primary interface to Diagnostic Imaging representing CT/AMI for design controls and risk management for QMS schema
  • Own, track, and drive ongoing design controls process improvements in both simplification and compliance.
  • Participant in audits and FDA inspections, and work with key SME to address and close audit/inspection findings.
  • Provide expertise, coaching and direction to engineering teams on effective and compliant approaches to creating deliverables and achieving project objectives.

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

Minimum Qualifications:

  • Bachelor's degree or higher in a technical or related field.
  • 7 or more years of experience in the area of design controls, risk management, Q&R, QMS and/or related fields.
  • Experience in dealing with QMS audits, CAPA, and FDA inspections.

Desired Qualifications:

  • Detailed experience in CFR 820.30, ISO14971, ISO62304 and/or ISO60601 a strong plus.
  • Strong organization skills with high attention to detail, demonstrated ability to manage and prioritize multiple activities, good planning, and ability to effectively deal with unanticipated issues.
  • Good communications skills, both up and down.
  • Demonstrated experience in working in global cross-functional teams, conflict resolution, and driving consensus.

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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