Quality Manager - Design Assurance
transfer of design to manufacturing, including process validation, DHF completeness, and production control plans...
transfer of design to manufacturing, including process validation, DHF completeness, and production control plans...
independently in doing thorough reviews/audit of Design History File (DHF) documentation for capital and disposable medical devices...
products Assisting with the creation of project plans and Design history Files (DHF) for each project Partnering...
for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design transfer. 2...
with distinct goals) Prepare and maintain Design History File (DHF) and always ensure readiness and availability for internal...
. Maintain design documentation such as DHF, specifications, drawings, and risk files. MPI does not discriminate on the basis...
management standards Knowledge of Design History File (DHF) and Device Master Record (DMR) requirements Understanding...
(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...
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...
suppliers, test labs, and manufacturing partners. Ensure documentation, DMR, and DHF organization, traceability, and test...