Quality Engineer – Medical Devices, CAPA & Risk

LivaNova PLC; Arvada (CO); On-site; USD 85,000 - 95,000; Full time

Job summary

LivaNova PLC is seeking a Quality Engineer in Arvada, Colorado, responsible for ensuring compliance with quality management systems and regulations in medical device manufacturing. Key functions include analyzing non-conforming products, leading investigations, and supporting quality management activities.

The ideal candidate will have a Bachelor’s Degree in a relevant field and 1-3 years of experience in the medical device industry. The position offers a competitive salary range of $85,000–$95,000 annually, along with bonus incentives.

Qualifications

• 1-3 years of related experience in Class II/III medical device manufacturing or related regulatory industry.
• Proficiency with quality tools such as flowcharts and statistical data analysis.
• ASQ Certified Quality Engineer or other ASQ certifications are a plus.

Responsibilities

• Support Quality Management in compliance with regulations.
• Analyze non-conforming products and propose product disposition.
• Lead investigations into component/product failures.

Skills

Regulatory requirements knowledge (FDA, ISO13485)

Data analysis and disposition decisions

Experience with CAPA

Excellent communication skills

Quality tools proficiency

Education

Bachelor’s Degree in Technical and Scientific disciplines

Job description

LivaNova PLC is seeking a Quality Engineer in Arvada, Colorado, responsible for ensuring compliance with quality management systems and regulations in medical device manufacturing. Key functions include analyzing non-conforming products, leading investigations, and supporting quality management activities.

The ideal candidate will have a Bachelor’s Degree in a relevant field and 1-3 years of experience in the medical device industry. The position offers a competitive salary range of $85,000–$95,000 annually, along with bonus incentives.