, such as DHF deliverables, SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity. Maintain knowledge of the...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...
(DHF) to ensure compliance with regulatory standards and internal quality requirements. This role is essential for guiding... with regulatory standards. Ensure that all DHF documentation is up-to-date and reflects the current design and development status...
, and IEC 60601. Document Control: Create, review, and maintain design history files (DHF) and other technical documentation...
. Support the preparation and maintenance of the software design history file (DHF) in alignment with FDA and international...
with high complexity and scope. Experience in risk management processes (e.g., CAPAs, DHF remediation, requirements...
., CAPAs, DHF remediation, requirements traceability). Skills Proficiency in usability engineering tools and techniques...
(i.e. BOMs, item masters, DHF, DMR, etc.) Excellent communication skills (oral and written). Able to work independently...
and process development. Applies principles of SDLC and owns product DHF while complying with QMS processes Designs...