Senior Medical Device QA Engineer - Quality Leader (Onsite)

Glidewell Dental; Irvine (CA); On-site; USD 99,000 - 120,000; Full time

Job summary

Glidewell Dental in Irvine, CA is seeking a Sr. QA Engineer to build quality into every stage of medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS activities.

You will work with R&D, Manufacturing, and Regulatory Affairs to ensure compliance with FDA/ISO standards and lead audits and continuous improvement initiatives. This role is fully onsite with a strong emphasis on leadership and quality ownership.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical field.
• Minimum 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry.
• Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
• Hands-on experience with ISO 14971, design controls, and validation methodologies.
• Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) or Six Sigma certification preferred.
• Experience with combination products or Class I/II medical devices preferred.
• Familiarity with EU MDR and UDI regulatory requirements preferred.

Responsibilities

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
• Lead CAPA investigations, non-conformance management, and root cause analysis.
• Own and improve elements of the QMS, including document control, internal audits, supplier quality, and change control.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs on design control, risk management, and product development lifecycle activities.
• Lead internal and supplier audits, and support external audits and inspections (FDA, Notified Bodies).
• Participate in IQ/OQ/PQ validations for processes, equipment, and software used in manufacturing and quality operations.
• Develop, monitor, and analyze quality metrics; drive continuous improvement and CAPA effectiveness.
• Provide quality engineering support to QC, including guidance on inspection methods, metrology, and measurement system capability.
• Investigate NCRs, complaints, deviations; implement effective corrective and preventive actions.
• Lead and mentor junior engineers, fostering growth and a culture of quality.
• Integrate ISO 14971 risk management and IEC 62366 usability activities.
• Ensure QMS training and internal communication.
• Coordinate pilot production, process validations, and risk analyses for new products and processes.
• Ensure calibration and preventive maintenance systems meet requirements.
• Identify Lean/Six Sigma opportunities to improve manufacturability and efficiency.
• Identify opportunities for equipment/tool redesign to improve quality.
• Perform other duties as assigned.

Skills

Analytical skills

Problem-solving

Communication skills

Project management

Quality certification awareness

Education

Bachelor's degree in Engineering, Science, or related field

CQE/CQA or Six Sigma certification (preferred)

Tools

Minitab

Job description

Glidewell Dental in Irvine, CA is seeking a Sr. QA Engineer to build quality into every stage of medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS activities.

You will work with R&D, Manufacturing, and Regulatory Affairs to ensure compliance with FDA/ISO standards and lead audits and continuous improvement initiatives. This role is fully onsite with a strong emphasis on leadership and quality ownership.