Staff Engineer, Quality

About the role

Stryker's Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts is hiring a Staff Quality Engineer. The role supports manufacturing operations, supplier quality and process performance across existing and new products, working with operations, engineering, suppliers and cross-functional partners so that products and processes meet quality standards, regulatory requirements and customer expectations. It is a key position on a newly integrated business preparing for commercial launch, acting as the site's primary Quality Engineer.

Key responsibilities

• Support manufacturing readiness, product transfer and the transition from development to sustaining operations.
• Identify and implement process improvements for quality, efficiency, inspection effectiveness and compliance.
• Lead investigations of internal and supplier nonconformances and own CAPAs, using root cause analysis.
• Review and dispose of nonconforming product through Material Review Board activities and containment actions.
• Partner with operations and cross-functional teams to resolve quality issues and maintain compliance.
• Evaluate quality metrics, identify trends and drive continuous improvement.
• Support manufacturing complaints, product field actions and quality investigations.
• Review and approve change management activities and verify quality controls.
• Support process validation, equipment qualification, measurement system analysis, audits and supplier quality performance.

Required profile

• Minimum bachelor's degree in Engineering, Quality, Life Sciences or a related technical discipline.
• At least 4 years of experience in Quality Engineering, Quality Assurance or a related quality role supporting manufacturing in a regulated environment.
• Preferred: experience in medical device manufacturing.

Required skills

• Preferred: training or certification in Lean, Lean Six Sigma or continuous improvement.
• Preferred: process capability analysis, statistical sampling plans and Gage R&R studies.
• Preferred: working knowledge of ISO 13485, GMP, CAPA, risk management, audits and statistical quality methods.

The role is onsite with 10% travel, and the pay range is $107,200 - $178,600 USD annually.