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 :

• 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...