Sr Quality Engineer - Exempt
performance reviews, and test method validation. Perform DHF audits and mechanical drawing review and approval per ASTM...
performance reviews, and test method validation. Perform DHF audits and mechanical drawing review and approval per ASTM...
requirements. Supporting new product development by updating and auditing Design History Files (DHF). Remediating design output...
independently in doing thorough reviews/audit of Design History File (DHF) documentation for capital and disposable medical devices...
transfer of design to manufacturing, including process validation, DHF completeness, and production control plans...
with distinct goals) Prepare and maintain Design History File (DHF) and always ensure readiness and availability for internal...
and upkeep of Design History File (DHF) documentation and support compliance with 21 CFR 820.30 Design Controls and ISO 14971... verification and validation activities, contribute to human factors assessments, and help maintain DHF and risk management...
and upkeep of Design History File (DHF) documentation and support compliance with 21 CFR 820.30 Design Controls and ISO 14971... verification and validation activities, contribute to human factors assessments, and help maintain DHF and risk management...
(DHF) specifications and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management. The engineer... factors, along with owning all the DHF and risk management deliverables to ensure the safety and efficacy of new and existing...
reports that support product validation and performance assessment. 5. Familiarity with design history files (DHF), device...
reports that support product validation and performance assessment. 5. Familiarity with design history files (DHF), device...