Service Quality Engineer

About the role

Service Quality Engineers bridge the gap between quality management systems and service delivery, ensuring customer needs, regulatory requirements, and internal standards are met.

Key responsibilities

• Facilitate and manage QMS activities across departments, sites, and businesses.
• Lead or participate in process improvement initiatives under regulatory scope.
• Support internal and external audits, ensuring compliance with standards such as ISO 13485, MDSAP, MDD, EU‑MDR, and CFR.
• Initiate and manage CAPA to address defects, non‑conformances, and quality notifications.
• Apply risk assessment tools and principles to service and delivery processes.
• Assess software as a medical device, review tests, analyze market feedback, and perform root‑cause analysis.

Required profile

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 2+ years of experience in Quality Engineering, Safety Engineering, Process Engineering or equivalent; 3+ years preferred in medical device industry.

Required skills

• Knowledge of ISO 13485, MDSAP, MDD, EU‑MDR, CFR standards.
• Experience with CAPA, PFMEA, risk assessment tools, and QMS support.

What we offer

• Salary range $92,000 – $130,000 annually.
• Comprehensive benefits including generous PTO, 401k match up to 7%, HSA contributions, stock purchase plan, and education reimbursement.