Senior Quality Engineer - MedTech Impact Leader

LivaNova; Arvada (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

LivaNova is seeking a Senior Quality Engineer to support Quality Engineering management in the design, manufacture, and regulatory compliance of medical devices. The role involves leading investigations into nonconforming products, driving CAPA, and coordinating audits to ensure patient safety and regulatory adherence.

The position requires strong analytical skills, experience in medical device manufacturing (Class II/III preferred), and ASQ QE certification is a plus.

Qualifications

• Bachelor's degree in technical/scientific disciplines (Physics, Chemistry, Engineering, Biology) or equivalent experience.
• Minimum 6–8 years in medical device manufacturing, preferably Class II/III.
• ASQ Certified Quality Engineer or similar certification is a plus.

Responsibilities

• Support Quality Engineering management for design and manufacture in compliance with QMS and regulatory requirements.
• Coordinate internal and external audits and report on QMS to company managers.
• Lead investigations into nonconforming products and CAPA to minimize regulatory and patient risk.
• Develop and maintain risk management documentation and evidence for Stop Shipments or Field Actions when needed.
• Collaborate with suppliers and engineering on design controls, process validation, and changes.

Skills

Quality engineering

Medical device

Statistical data analysis

ASQ Certification

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in engineering/technical field

Tools

Quality tools

CAPA tools

Job description

LivaNova is seeking a Senior Quality Engineer to support Quality Engineering management in the design, manufacture, and regulatory compliance of medical devices. The role involves leading investigations into nonconforming products, driving CAPA, and coordinating audits to ensure patient safety and regulatory adherence.

The position requires strong analytical skills, experience in medical device manufacturing (Class II/III preferred), and ASQ QE certification is a plus.