quality engineering functions, including Design History File (DHF) management, supplier audits, and management of the..., etc.) and ensures documentation is complete and audit ready. Design History File (DHF) & Product Development Support: Reviews...
or quality assurance Experience with ISO 14971 risk management Design controls / DHF documentation 510(k), De Novo, or PMA...
complaints and non-conformances, while proactively managing the Design History File (DHF) and Risk Management activities...
Files (DHF) and risk management documentation Work with external partners to review product designs and development... management Experience with Design History Files (DHF) preferred Strong communication and technical writing skills Ability...
Files (DHF) and risk management documentation Work with external partners to review product designs and development... management Experience with Design History Files (DHF) preferred Strong communication and technical writing skills Ability...
and ensure compliance with IEC 62304/82304. Support supplier qualification, design transfer, and DHF completeness. Contribute...
activities and supports critical quality engineering functions, including Design History File (DHF) management, supplier audits... (e.g., FDA eMDR, EU Vigilance, etc.) and ensures documentation is complete and audit ready. Design History File (DHF...
, and reliability requirements are met. Owns and drives design control documentation, including DHF elements (design inputs, outputs...
specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports...
Contribute to design history file (DHF) creation including design review meetings, phase signoffs, and final transitions... to manufacturing. Learn and support the design control process (DMR, DHF, Technical Files, etc.) Create drawings, documentation...