Quality Engineer II

For our client, we are seeking a Quality Engineer II to join the team of a leader in the Healthcare space.

This role will support quality engineering efforts across medical device development and manufacturing, with a strong focus on compliance, risk management, and product quality. The position will partner closely with engineering, manufacturing, and quality teams to investigate issues, strengthen controls, and support continuous improvement. The ideal candidate will help ensure products and processes meet rigorous regulatory and quality standards while contributing to better patient outcomes.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $150,000 – $157,500 annually

Responsibilities

• Apply biomedical systems engineering and quality assurance principles to product development
• Investigate manufacturing problems and product complaints to determine root causes
• Maintain quality system information databases and prepare reports on quality data
• Provide quality oversight for new product design and development
• Process Non-Conforming Material Reports and manage nonconformance issues
• Ensure compliance with design control requirements and risk management practices
• Conduct internal and external audits to verify compliance with quality standards

Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering or a related field
• 5 years of experience as a Quality Engineer in medical devices, or 3 years with a Master’s degree
• Proficiency in ISO 14971, 21 CFR Part 820, and ISO 13485
• Experience with medical device complaints, NCMRs, and CAPAs
• Familiarity with Minitab, Gage R&R, and change control review

Benefits

• Remote work flexibility from anywhere in the U.S.
• Opportunity to work with cutting-edge medical technology
• Engagement in a collaborative and innovative team environment
• Professional development opportunities in quality engineering
• Contribution to improving patient care through quality assurance

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.