of implantable device DHF's to ensure compliance. Required Qualifications: Bachelor's degree in mechanical engineering, Biomedical...
, change management, and inspection. Process electronic DHF documents in the PLM database. Review documents for formatting...
Files (DHF) for new and existing products. Ensure all laboratory activities comply with applicable FDA, OSHA, EPA, ISO...
history file (DHF) compilation, and third-party certification. Duties and Responsibilities Lead and manage multiple R.../output updates, verification and validation (V&V) testing, design history file (DHF) compilation, and third-party...
and oversee content of the Device Master Record (DMR) for accuracy and compliance. Audit Design History File (DHF...
years of experience preferred Experience with Design History Files (DHF) preferred Ability to follow instructions...
controls and risk management Led and managed development of DHF (design history file) deliverables for medical devices...
History Files (DHF) Quality & Compliance Perform work in compliance with ISO 13485, QSR, and internal quality systems...
documents Revision management Document lifecycle and approvals DHF/DMR related documentation processes Compliance...
. Ensure compliance with FDA QSR, ISO 13485, ISO 9001, and GMP requirements. Maintain Design History Files (DHF) and support...