QA Engineering Manager - Medical Devices, Onsite Irvine

Glidewell Dental; Irvine (CA); On-site; USD 114,000 - 152,000; Full time

Job summary

Glidewell Dental is seeking a senior quality assurance leader to oversee the quality system for development and contract manufacturing of medical products. You will lead the QA engineering team, ensure regulatory compliance, and drive process improvements across NPI projects at our Irvine campus.

The role requires extensive QA management experience, deep knowledge of ISO 13485, and strong collaboration with design, manufacturing, and regulatory teams to ensure timely, compliant product delivery.

Qualifications

• Bachelor’s degree in a related engineering discipline.
• Minimum seven (7) years of related quality assurance experience.
• Previous management and leadership experience.
• Advance knowledge with development and test requirements with recognized standards (ISO 13485).
• Previous experience with New Product Development.
• Demonstrated knowledge of regulatory requirements for software applications including SaMD.
• Demonstrated ability to implement and improve Software QMS processes.
• Previous quality assurance experience in materials manufacturing, preferred.

Responsibilities

• Oversee and improve the company quality system to support development and contract manufacturing of medical products.
• Lead, coach, and set goals for the Quality Engineering team.
• Ensure compliance with US and international regulations and manage audits.
• Collaborate on EPDs, product designs, and data analysis to support NPI and process improvements.
• Address employee relations matters in coordination with HR as needed.
• Prepare reports on department metrics and present performance to management.

Skills

Leadership

Regulatory knowledge

Software QA

Quality Assurance

Education

Bachelor’s degree in a related engineering discipline

Job description

Glidewell Dental is seeking a senior quality assurance leader to oversee the quality system for development and contract manufacturing of medical products. You will lead the QA engineering team, ensure regulatory compliance, and drive process improvements across NPI projects at our Irvine campus.

The role requires extensive QA management experience, deep knowledge of ISO 13485, and strong collaboration with design, manufacturing, and regulatory teams to ensure timely, compliant product delivery.