Manager, Combination Products and Medical Devices (all genders) (fulltime, regular)
Core
Represent QA on cross-functional combination product and medical device development teams to ensure compliance with worldwide regulations.
Role type
Manager, Quality Assurance (Medical Devices & Combination Products)
Builds
Combination products and medical devices
Domain
Healthcare / Medical Devices / Quality Assurance
Required skills
Quality Assurance, Medical Device Regulations, Design Control, Risk Management (FMEA), Supplier Management, Technical Product Development, Negotiation, Analytical Problem Solving
Preferred skills
Combination Product experience, 3rd party supplier management
Technologies
FMEA, Design Control Tools
Responsibilities
Lead product team members through the design process, Ensure design control documentation and change control requirements are met, Perform 3rd party supplier management and audits, Partner with vendors to ensure regulatory compliance, Foster global collaboration to identify and mitigate product risks, Identify gaps in existing processes and guide project development.
Seniority
Manager, hands-on IC