Design Quality Engineer

Job Title: Design Quality Engineer

Location: Raynham, MA

Duration: 12 Months

Responsibilities:

• Support DHF and QMS migration activities.
• Review design documentation, risk files, and V&V reports for quality and regulatory compliance.
• Review and approve design control documents with complete traceability.
• Support DHF remediation, document consolidation, and design transfer activities.
• Collaborate with R&D, Regulatory, Manufacturing, and Quality teams.
• Identify and close gaps related to ISO 13485, FDA 21 CFR 820, and EU MDR.
• Support audit preparation and inspection readiness.
• Participate in change control and assess quality/regulatory impact.
• Ensure compliance with internal QMS and applicable regulatory requirements.

Qualifications:

• Bachelor's/Master's degree in Biomedical, Mechanical, or related Engineering discipline.
• 5+ years of Design Quality Engineering experience in the medical device industry.
• Strong knowledge of DHF, DMR, DHR, and Design Controls.
• Experience with QMS migration, DHF remediation, and/or design transfer.
• Knowledge of ISO 13485, FDA 21 CFR 820, and EU MDR.
• Hands-on experience with ISO 14971 risk management, V&V, and change control.