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The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The ideal candidate will lead product transfers and ensure compliance with industry regulations while fostering a collaborative and innovative work environment.
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Job Summary
The role requires leading integrated Master Transfer Plans spanning sending and receiving sites while ensuring alignment with corporate strategy.
Candidates must drive operational readiness including cleanroom, EHS, and facilities readiness while managing equipment installation and validation protocols.
Success in this position demands zero major non-conformances during audits and regulatory inspections while meeting strict timelines and budget targets.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The ideal candidate will lead product transfers and ensure compliance with industry regulations while fostering a collaborative and innovative work environment.
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Skills & Requirements
Must-have
8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
ISO 13485 and FDA 21 CFR 820 compliance
Process validation IQ OQ PQ protocols
Cross-functional stakeholder management
Nice-to-have
PMP or Prince2 certification preferred
Lean Six Sigma credentials
Strong coaching and conflict resolution skills
International travel up to 60% capability
Experience with EU/US logistics and import clearance
Key Requirements
Bachelor's degree in engineering or Project Management