Senior Quality Engineer, Medical Devices

ICU Medical Inc; Highland (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

ICU Medical Inc in Indiana is seeking a Quality Engineer to provide quality support and ensure compliance with ISO 13485, 14971, and 21 CFR Part 820 across hardware, software, and consumables.

You will participate in design reviews, risk assessments, audits, CAPA, and regulatory submissions, helping to integrate quality into product realization and manufacturing. Travel up to 5–10% may be required.

Qualifications

• Bachelor’s degree in engineering is required.
• 7+ years in quality engineering in the medical device field.
• ASQ CQE or CSQE required or obtainable within one year.
• Experience with ISO 13485, ISO 14971, IEC 60601, IEC 62304.

Responsibilities

• Ensure product safety by managing lifecycle to meet quality system requirements.
• Maintain compliance with ICU Medical quality system and practices.
• Utilize quality tools to assure product quality across design and manufacturing.
• Prepare for internal/external audits and inspections.
• Lead design reviews, test readiness, risk assessments, and code reviews.
• Support regulatory submissions and responses to inquiries.
• Work on special projects as assigned.

Skills

Quality compliance

Audit & investigation

Quality Management Systems

Risk management

FDA MDR knowledge

Systems thinking

Cross-functional collaboration

New product development

Education

Bachelor's in engineering

ASQ CQE or CSQE

Tools

CAPA tools

Job description

ICU Medical Inc in Indiana is seeking a Quality Engineer to provide quality support and ensure compliance with ISO 13485, 14971, and 21 CFR Part 820 across hardware, software, and consumables.

You will participate in design reviews, risk assessments, audits, CAPA, and regulatory submissions, helping to integrate quality into product realization and manufacturing. Travel up to 5–10% may be required.