Staff Engineer, Quality

Stryker Corporation; Waltham (MA); Hybrid; USD 107,000 - 179,000; Full time

Job summary

Stryker Corporation in Waltham, Massachusetts is seeking a Staff Quality Engineer to support manufacturing operations and supplier quality for AVS products. You will drive process performance for existing and new products, collaborating with operations, engineering, and cross-functional partners to ensure quality standards, regulatory compliance, and customer expectations.

As the site’s primary Quality Engineer, you will establish quality metrics, lead CAPA activities, support manufacturing

Qualifications

• Minimum bachelor’s degree in Engineering, Quality, Life Sciences, or 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.

Responsibilities

• Support manufacturing readiness, product transfer activities, and 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 experience

Regulated manufacturing environment

Education

Bachelor's degree in Engineering or Quality or Life Sciences

Tools

CAPA processes

Gage R&R and SPC

Job description

Work Flexibility: Onsite 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 View 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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.