CT/AMI R&D Design Controls Leader (SG70)
Job TitleCT/AMI R&D Design Controls Leader (SG70)
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
- 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.
- 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?
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