Job Description
Job Description
This person develops, implements, and maintains quality engineering methodologies and systems that meet company, customer, and regulatory requirements, with a strong focus on patient safety and product quality. They serve as a quality representative supporting visibility, execution, and communication of quality initiatives across cross‑functional teams. Provides focused quality engineering support for product sustaining activities, including Design History File (DHF) remediation and design controls to ensure documentation is complete, consistent, and inspection‑ready. Supports DHF remediation through gap assessments, documentation creation and updates, risk management alignment, and end‑to‑end traceability between design inputs, outputs, verification, and validation. They also collaborate with R&D, Manufacturing, Regulatory Affairs, and Document Control to drive remediation tasks to closure, maintain audit readiness, and ensure compliance within required quality syst...
This person develops, implements, and maintains quality engineering methodologies and systems that meet company, customer, and regulatory requirements, with a strong focus on patient safety and product quality. They serve as a quality representative supporting visibility, execution, and communication of quality initiatives across cross‑functional teams. Provides focused quality engineering support for product sustaining activities, including Design History File (DHF) remediation and design controls to ensure documentation is complete, consistent, and inspection‑ready. Supports DHF remediation through gap assessments, documentation creation and updates, risk management alignment, and end‑to‑end traceability between design inputs, outputs, verification, and validation. They also collaborate with R&D, Manufacturing, Regulatory Affairs, and Document Control to drive remediation tasks to closure, maintain audit readiness, and ensure compliance within required quality syst...