Staff Quality Engineer
Stryker
Summary
Stryker is seeking a Staff Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. In this role, you will partner with operations, engineering, suppliers, and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale up activities, lead continuous improvement initiatives, and ensure products meet applicable regulatory and quality requirements.
Job description
What You Will Do
- Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.
- Support the transfer, launch, and scale-up of new products and manufacturing processes, partnering cross-functionally to establish robust quality systems and ensure successful production readiness.
- Lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and implementation of corrective actions.
- Review and disposition nonconforming materials and products through Material Review Board processes.
- Collaborate with suppliers to address quality issues, manage supplier corrective actions, and support supplier quality improvement initiatives.
- Evaluate and support manufacturing, supplier, and engineering changes to ensure compliance with quality and regulatory requirements.
- Monitor quality performance indicators, analyze trends, and implement actions to address identified risks and improvement opportunities.
- Lead or support continuous improvement initiatives focused on quality enhancement, scrap reduction, efficiency gains, and cost savings.
- Support process validation, equipment qualification, inspection methods, measurement system analysis, and statistical process controls.
- Participate in internal and external audits, complaint investigations, field actions, and continuous improvement projects across manufacturing operations.
What You Will Need
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- Minimum 4 years of quality engineering, manufacturing engineering, or related engineering experience.
- Experience supporting non-conformance investigations, corrective and preventive actions, or quality management systems.
Preferred Qualifications
- Experience in the medical device industry.
- Experience analyzing quality data and applying statistical methods to support manufacturing or process improvements.
- Six Sigma Green Belt or Six Sigma Black Belt certification.
- Experience with geometric dimensioning and tolerancing (GD&T).
- Experience using metrology equipment such as calipers, micrometers, pin gauges, or coordinate measuring machines (CMMs).
Requirements
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- Minimum 4 years of quality engineering, manufacturing engineering, or related engineering experience.
- Experience supporting non-conformance investigations, corrective and preventive actions, or quality management systems.
- Experience in the medical device industry.
- Experience analyzing quality data and applying statistical methods to support manufacturing or process improvements.
- Six Sigma Green Belt or Six Sigma Black Belt certification.
- Experience with geometric dimensioning and tolerancing (GD&T).
- Experience using metrology equipment such as calipers, micrometers, pin gauges, or coordinate measuring machines (CMMs).
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.