of implantable device DHF's to ensure compliance. Required Qualifications: Bachelor's degree in mechanical engineering, Biomedical...
(traceability, linkages) and change control requirements are met. Identify and close gaps in Design History Files (DHF) and Risk...
efficient long-term solutions. Ensure DHF content integrity, completeness, and regulatory / standards compliance...
and completeness of the Design History File (DHF) Ensure alignment between DHF and Device Master Record (DMR) during design transfer... assessment on DHF and risk management files, implementation of corrective actions, and verification of effectiveness...
(traceability, linkages) and change control requirements are met. Identify and close gaps in Design History Files (DHF) and Risk...
, and validation. Support design reviews, phase gate readiness, and Design History File (DHF) completeness. Lead and support risk...
, with the purpose of identifying the underlying issues and offering efficient long-term solutions. Ensure DHF content integrity...
design verification and DHF deliverables Build and maintain Product Specification Files (PSF) for Clients program Skills... as QA Signed off on design development plan, completed design verification, approved DHF deliverables Good understanding...
, phase gate readiness, and Design History File (DHF) completeness. Lead and support risk management activities per ISO 14971...
21 CFR Part 820 and ISO 13485. Author and maintain inspection-ready Design History Files (DHF). Support regulatory...