Philips CT/AMI R&D Design Controls Leader (SG70) in Highland Heights, Ohio
The Computed Tomography / Advanced Molecular Imaging Research & Development (CT/AMI R&D) Design Controls Leader is the process owner for Design Controls related Standard Operating Procedures (SOPs), Working Instructions (WI), and templates. The CT/AMI R&D Design Controls Leader will work hand in hand with Quality & Regulatory (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 for tracking major regulatory changes and ensuring compliance to ongoing changes.
Work with Q&R to establish and maintain a compliant design controls process.
Monitor the regulatory landscape, establish compliance roadmaps, and ensure adequate plans are in place to address ongoing regulatory changes.
Own, track, and drive Quality Management System (QMS) Operationalization activities within R&D
Own, track, and drive ongoing design controls process improvements in both simplification and compliance.
Participant in audits and FDA inspections, and work with key Subject Matter Expert (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.
Bachelor’s degree or higher in a technical or related field.
7 or more years of experience in the area of design controls, Q&R, QMS and/or related fields. Detailed experience in CFR 820.30, ISO14971, IEC62304, and/or ISO60601 a strong plus.
Experience in dealing with QMS audits, CAPA, and FDA inspections.
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.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Apply today!
Find out more info about Philips at www.philips.com/na/careers
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.