Staff Quality Engineer – Launch Readiness & Process Improvement

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

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.