Quality Manager II, Combination Products & Medical (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
Senior IC 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, Change Control, Cross-functional Collaboration
Preferred skills
Combination Product experience, 3rd party supplier management experience
Technologies
FMEA, Design Control Tools
Responsibilities
Lead product team members through the design process; Ensure design control 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.
Seniority
Senior, hands-on IC