Staff Engineer, Quality
Stryker
Summary
Join Stryker's Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Quality Engineer. In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross-functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations.
Job description
This role offers a unique opportunity to support a newly integrated business preparing for commercial launch. As the site's primary Quality Engineer, you will play a key role in helping to establish quality metrics, drive process improvements, support manufacturing readiness activities, and enhance long-term quality and operational performance.
What You Will Do
- Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.
- Identify and implement process improvements that enhance product quality, manufacturing efficiency, inspection effectiveness, and compliance.
- Lead investigations of internal and supplier nonconformances, ensuring timely resolution and closure.
- Own Corrective and Preventive Actions (CAPAs), using root cause analysis to identify issues and implement sustainable solutions.
- Review and disposition nonconforming product through Material Review Board activities and containment actions.
- Partner with operations and cross-functional teams to resolve quality issues and maintain process compliance.
- Evaluate manufacturing and quality performance metrics, identify trends, and drive continuous improvement initiatives.
- Support manufacturing complaints, product field actions, and quality-related investigations.
- Review and approve change management activities, challenge effectiveness, and verify implementation of quality controls.
- Support process validation, equipment qualification, measurement system analysis, audits, and supplier quality performance activities.
What You Will Need
Required Qualifications
- Minimum bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
- Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related quality-focused role supporting manufacturing operations within a regulated environment.
- Experience working within a regulated manufacturing environment.
Preferred Qualifications
- Experience in medical device manufacturing.
- Training or certification in Lean, Lean Six Sigma, or continuous improvement methodologies.
- Experience with process capability analysis, statistical sampling plans, and gauge repeatability and reproducibility (Gage R&R) studies.
- Working knowledge of ISO 13485, Good Manufacturing Practices (GMP), CAPA, risk management, audits, and statistical quality methods
Requirements
- Minimum bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
- Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related quality-focused role supporting manufacturing operations within a regulated environment.
- Experience working within a regulated manufacturing environment.
- Experience in medical device manufacturing.
- Training or certification in Lean, Lean Six Sigma, or continuous improvement methodologies.
- Experience with process capability analysis, statistical sampling plans, and gauge repeatability and reproducibility (Gage R&R) studies.
- Working knowledge of ISO 13485, Good Manufacturing Practices (GMP), CAPA, risk management, audits, and statistical quality methods
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.