Staff Engineer, Quality

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

Job summary

Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts seeks a Staff Quality Engineer to support manufacturing operations, supplier quality, and process performance. You will help ensure products meet quality standards, regulatory requirements, and customer expectations as the site’s primary Quality Engineer.

You will lead CAPA initiatives, drive continuous improvement, assist in product transfers, and collaborate with cross-functional teams to optimize quality and

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 in medical device manufacturing (preferred).
• Experience with ISO 13485, GMP, CAPA, risk management, audits, and statistical quality methods (preferred).

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, audits, and supplier quality performance activities.

Skills

Quality engineering

Root cause analysis

CAPA implementation

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

Gage R&R

Process validation

Statistical methods

Job description

## Staff Engineer, QualityApply: Waltham, Massachusetts: Full time: Posted Today: R573401Work Flexibility: OnsiteJoin **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 AnnualView the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.