Senior Engineer, Quality Assurance
Stryker
Summary
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 that shape 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.
Job description
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.
Requirements
- 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.
- 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.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.