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 and approve manufacturing change orders and MDR-related updates
• Support labeling verification, packaging testing, and technical documentation updates
• Maintain documentation and change records within Agile PLM
• Process validation and test method validation experience
• PFMEA, Control Plan, and risk management expertise
• Experience with FAIs, dimensional verification, and manufacturing changes
• Knowledge of FDA 21 CFR Part 820 and EU MDR (2017/745)
• Familiarity with ISO 13485, ISO 14971, and IEC 60601
• Experience with change control and medical device quality systems

Education & Experience :

• Bachelor's degree in Engineering or related discipline
• 4+ years of relevant experience (MDR experience highly preferred)
• DOE/Minitab experience
• Computer System Validation (CSV)
• SOP development
• gile PLM experience
• Packaging validation and fit testing