Staff Engineer, Quality

Stryker Group; Waltham (MA); On-site; USD 107,000 - 179,000; Full time

Job summary

Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts is seeking a Staff Quality Engineer. In this role you will support manufacturing operations, supplier quality, and process performance across both existing and new products.

You will work closely with operations, engineering, suppliers, and cross‑functional partners to ensure products meet quality standards, regulatory requirements, and customer expectations.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences or related technical discipline.
• Minimum 4 years of experience in Quality Engineering/QA supporting manufacturing in a regulated environment.
• Experience in a regulated manufacturing environment.

Responsibilities

• Support manufacturing readiness, product transfers, and development-to-sustaining transitions.
• Identify and implement process improvements to enhance quality and efficiency.
• Lead investigations of internal and supplier nonconformances with timely closure.
• Own CAPAs and use root-cause analysis for sustainable solutions.
• Review disposition of nonconforming product via MRB and containment actions.
• Partner with operations to resolve quality issues and maintain compliance.
• Evaluate quality metrics, identify trends, and drive improvements.
• Support manufacturing complaints, field actions, and quality investigations.
• Review and approve change management activities and verify controls.
• Support process validation, equipment qualification, and audits.
• Coordinate supplier quality performance activities.

Skills

Quality Engineering

Quality Assurance

CAPA

Lean Six Sigma

Education

Bachelor's degree in Engineering, Quality, Life Sciences

Tools

Process capability analysis

Gage R&R

Statistical sampling

Job description

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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