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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.