Quality Manager II, Combination Products & Medical (all genders) (fulltime, regular)
Core
Ensure compliance with worldwide Combination Product and Medical Device Regulations for products developed, manufactured, tested, and procured.
Role type
Senior Quality Manager (Combination Products & Medical Devices)
Builds
Combination products and medical devices
Domain
Healthcare / Medical Devices / Combination Products
Required skills
Quality Assurance, Design Control, Risk Management (FMEA), Supplier Management, Regulatory Compliance, Technical Product Development
Preferred skills
Combination Product experience, 3rd party supplier management
Technologies
FMEA, Design Control Documentation
Responsibilities
Represent QA on cross-functional development teams, lead product teams through design process, manage 3rd party supplier quality and audits, assess impact of design changes on safety/efficacy, identify process gaps, guide global product development teams on QA expertise.
Seniority
Senior, hands-on IC