Quality Engineering Senior

Senior Quality Engineer
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 and responsibilities include:

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 and 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
• Agile PLM experience
• Packaging validation and fit testing