Design Quality Engineer II

ySeeking a Design Quality Engineer III to support Design History File (DHF) remediation and design control activities for sustaining medical device products. The role focuses on ensuring design documentation is complete, compliant, traceable, and audit-ready while collaborating with cross-functional teams

. Key Responsibiliti

• esSupport DHF remediation, gap assessments, and documentation update
• s.Create and maintain Design Inputs, Design Outputs, Design Reviews, Verification & Validation documents, and Traceability Matrice
• s.Update and maintain risk management documentation, including DFMEA, Hazard Analysis, and Risk Control
• s.Ensure traceability between design requirements, risk controls, verification, and validation activitie
• s.Partner with R&D, Manufacturing, Regulatory Affairs, and Document Control team
• s.Support audit and inspection readiness activitie
• s.Track remediation progress and drive assigned deliverables to completio

• onsBachelor’s degree in Engineering or related fie
• ld.3+ years of medical device industry experien
• ce.Strong knowledge of Design Controls, DHF documentation, and Quality Syste
• ms.Experience with risk management documentation (DFMEA, Hazard Analysis, Risk Control
• s).Familiarity with product lifecycle documentation and engineering change process
• es.Strong technical writing, documentation, and problem-solving skil

ls. Preferred Qualificat

• ionsExperience with DHF remediation proje
• cts.Knowledge of FDA Quality System Regulations and medical device standa
• rds.Experience supporting audits and regulatory inspecti