Staff Quality Engineer - Manufacturing Readiness & CAPA Leader

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts is seeking a Staff Quality Engineer to support manufacturing operations, supplier quality, and process performance for existing and new products.

As the site’s primary Quality Engineer, you will establish quality metrics, drive process improvements, support manufacturing readiness activities, and ensure products and processes meet regulatory requirements and customer expectations.

Qualifications

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

Responsibilities

• 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 CAPAs, using root cause analysis to identify issues and implement sustainable solutions.
• Review and disposition nonconforming product through MRB 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.

Skills

Quality Engineering

Regulated manufacturing

CAPA

Root cause analysis

Gage R&R

Lean Six Sigma

ISO 13485

GMP

Process validation

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Job description

Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts is seeking a Staff Quality Engineer to support manufacturing operations, supplier quality, and process performance for existing and new products.

As the site’s primary Quality Engineer, you will establish quality metrics, drive process improvements, support manufacturing readiness activities, and ensure products and processes meet regulatory requirements and customer expectations.