KH
Senior Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
4 months ago
- Risk Management
- Agile
- PFMEA
- IEC
- Minitab
4 months ago
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
- 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
Senior Quality Engineer · Katalyst Healthcares & Life Sciences