Opportunity Description
Summary :
Seeking a Senior Quality Engineer with strong MDR remediation and medical device manufacturing quality experience to support compliance, validation, and risk management activities for regulated product families.
Roles & Responsibilities :
Seeking a Senior Quality Engineer with strong MDR remediation and medical device manufacturing quality experience to support compliance, validation, and risk management activities for regulated product families.
Roles & Responsibilities :
- Support MDR remediation and manufacturing quality assurance activities
- Develop and maintain PFMEAs, Control Plans, and risk management documentation
- Conduct First Article Inspections (FAIs), dimensional verification, and packaging evaluations
- Perform process validation activities including IQ, OQ, PQ, and test method validations
- Conduct production floor assessments and process observations to support risk evaluations
- Collaborate with Manufacturing, Quality, Warehouse, Planning, and Product Engineering teams
- Review a...
Ready to Apply?
Submit your application for Senior Quality Engineer at Katalyst Healthcares & Life Sciences
Apply for this Position