Senior Quality Engineer, MedTech — Global Impact

LivaNova PLC; Arvada (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

LivaNova is seeking an experienced Quality Engineer to join our Quality Engineering Management team. You will support design and manufacture in compliance with QMS and regulatory requirements, lead CAPA investigations, and participate in audits.

You will work with cross-functional teams to ensure product quality, develop robust quality plans, and drive continuous improvement across processes. Travel 20% is required as part of collaborating with suppliers and manufacturing sites.

Qualifications

• Excellent communication and presentation skills.
• 6–8 years of related experience in medical device manufacturing.
• In-depth or breadth of engineering skill(s).
• Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
• Ability to work in a changing environment and with diverse teams.
• ASQ Certified Quality Engineer or related certifications are a plus.
• Knowledge of FDA/ISO regulatory requirements.
• Ability to analyze, problem-solve, and communicate across functional lines.

Responsibilities

• Support Quality Engineering Management for design and manufacture under QMS regulations.
• Lead investigations of nonconformances and CAPA activities with risk assessment.
• Coordinate and participate in internal and external audits and CAPA closures.
• Develop and maintain quality plans, process validation, and change control documentation.
• Provide daily support for complaint handling, V&V activities, and data trend analysis.

Skills

Communication skills

Quality engineering

Regulatory knowledge

Problem solving

Education

Bachelor's degree in technical/scientific disciplines

Job description

LivaNova is seeking an experienced Quality Engineer to join our Quality Engineering Management team. You will support design and manufacture in compliance with QMS and regulatory requirements, lead CAPA investigations, and participate in audits.

You will work with cross-functional teams to ensure product quality, develop robust quality plans, and drive continuous improvement across processes. Travel 20% is required as part of collaborating with suppliers and manufacturing sites.