Senior Medical Device QA Engineer - Quality Leadership

glidewelldental; 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 help build quality into every stage of our medical device development and manufacturing. You will own CAPA investigations, QMS improvements, and risk management across design, validation, and supplier quality.

You will collaborate with cross-functional teams to ensure compliance with FDA/ISO standards, support external audits, and drive process optimization using Lean/Six Sigma principles.

Qualifications

• Bachelor’s degree in engineering, science, or related field.
• Minimum 5 years QA/QE experience in medical devices.
• Strong knowledge of FDA/ISO quality standards.
• Experience with risk management and validation methods.

Responsibilities

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
• Lead CAPA investigations and root-cause analysis using 8D, Fishbone, and 5 Whys.
• Own and improve the QMS elements including document control, internal audits, supplier quality, and change control.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs throughout product lifecycle activities.
• Lead internal and supplier audits and support external regulatory inspections (FDA, Notified Bodies).
• Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software.

Skills

Analytical thinking

Problem solving

Communication skills

Project management

Statistical analysis

Education

Bachelor’s degree in Engineering, Science, or related technical field

CQE / CQA / Six Sigma certification (preferred)

Tools

Minitab

Job description

Glidewell Dental in Irvine, CA is seeking a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You will own CAPA investigations, QMS improvements, and risk management across design, validation, and supplier quality.

You will collaborate with cross-functional teams to ensure compliance with FDA/ISO standards, support external audits, and drive process optimization using Lean/Six Sigma principles.