Senior Engineer, Quality Assurance

Senior Quality Assurance Engineer Portage, MI

Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you’ll lead Emergency Care critical investigations and drive improvements for the Belfast, Northern Ireland site that shapes the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle.

Work Flexibility:

Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.

What you will do

• Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
• Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
• Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
• Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
• Author and manage nonconformance and corrective and preventive action records, including defined deliverables, action owners, timelines, and supporting documentation.
• Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
• Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

What you will need Required Qualifications

• Bachelor’s degree in science, engineering, or a related discipline.
• Minimum 2 years of experience in quality assurance or customer quality.
• Experience working in a regulated industry, such as medical devices or aerospace.
• Experience conducting post-market quality assessments.

Preferred Qualifications

• Master’s degree in science, engineering, or related discipline.
• Experience conducting product field actions.
• Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements.
• Six Sigma Green Belt certification or experience with formal investigative techniques.

$77,700 - $129,500 USD Annual