, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF...
best practices through entire corporate PDP Managing efforts for compliance ensure design control, DMR/DHF compliance, risk...
, including DHF elements, specifications, and test protocols. Lead and coordinate supplier qualification, incoming inspection...
collaboration. You’ll contribute to the creation of Design History Files (DHF), risk management files, and other engineering... Assist in developing and maintaining Design History Files (DHF) and Risk Management Files for medical devices and combination...
projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology...
for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design transfer. 2...
, maintaining, and managing essential documentation such as Design History Files (DHF) and Device Master Records (DMR) Excellent...
requirements. Supporting new product development by updating and auditing Design History Files (DHF). Remediating design output...
performance reviews, and test method validation. Perform DHF audits and mechanical drawing review and approval per ASTM...