MedTech Quality Engineer - CAPA & Compliance

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

Job summary

LivaNova is seeking a Quality Engineer in Arvada, Colorado, to ensure compliance with its quality management system for medical devices. This role involves evaluating non-conforming products, leading CAPA projects, and improving product quality.

The ideal candidate should possess a Bachelor's Degree in a technical field and have 1-3 years of experience in the medical device industry, along with knowledge of FDA and ISO standards. The salary range is $85,000-$95,000, plus an annual bonus.

Qualifications

• Minimum 1-3 years of experience in Class II/III medical device manufacturing.
• Knowledge of FDA and ISO 13485 regulations.
• Experience with MDSAP and regulatory requirements is a plus.

Responsibilities

• Evaluate non-conforming products and propose CAPA.
• Analyze product complaints for improvements.
• Lead CAPA projects and data trend analysis.

Skills

Quality tools proficiency

Regulatory knowledge (FDA, ISO 13485)

Data analysis

Problem-solving ability

Communication skills

Education

Bachelor’s Degree in Technical and Scientific disciplines

Job description

LivaNova is seeking a Quality Engineer in Arvada, Colorado, to ensure compliance with its quality management system for medical devices. This role involves evaluating non-conforming products, leading CAPA projects, and improving product quality.

The ideal candidate should possess a Bachelor's Degree in a technical field and have 1-3 years of experience in the medical device industry, along with knowledge of FDA and ISO standards. The salary range is $85,000-$95,000, plus an annual bonus.