Staff Engineer, Quality

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.

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

US20 : $107,200 - $178,600 USD Annual

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