Medical Device QA Engineer - ISO 13485 & CAPA Expert

glidewelldental; Irvine (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Glidewell Dental seeks a Quality Assurance Engineer to drive quality across medical device development and manufacturing. You will own QA activities, risk management, CAPA, validation, and our Quality Management System, partnering with cross‑functional teams to ensure safety, performance, and compliance.

Ideal candidates have a minimum of 3 years in quality engineering, knowledge of FDA/ISO13485, ISO14971, and strong analytical skills.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred).
• At least 3 years of quality engineering and risk management experience.
• Knowledge of FDA regulations, ISO 13485, and other quality standards.
• Experience with ISO 14971 risk management and design controls.
• Proficiency in Minitab or equivalent quality tools.
• CQE, CQA or Six Sigma certification is a plus.
• Experience with medical devices (Class I/II) preferred.
• Familiarity with EU MDR and UDI requirements preferred.

Responsibilities

• Lead quality assurance and quality engineering activities to ensure products meet requirements.
• Support CAPA, NCR investigations, and root cause analysis.
• Collaborate on testing, validation, and risk assessment across departments.
• Analyze data and trends and report results to management.
• Participate in design verification testing for design control projects.

Job description

Glidewell Dental seeks a Quality Assurance Engineer to drive quality across medical device development and manufacturing. You will own QA activities, risk management, CAPA, validation, and our Quality Management System, partnering with cross‑functional teams to ensure safety, performance, and compliance.

Ideal candidates have a minimum of 3 years in quality engineering, knowledge of FDA/ISO13485, ISO14971, and strong analytical skills.