Staff Advanced Quality Engineer
stryker· Stryker Employment Company, LLC
About this role
Work Flexibility: Hybrid
Staff Advanced Quality Engineer
Portage, MI
Join a team focused on advancing quality throughout the product development lifecycle in a regulated medical device environment. As a Staff Advanced Quality Engineer, you will collaborate with engineering, manufacturing, and project teams to ensure products meet quality, regulatory, and user requirements from concept through commercialization. This role offers the opportunity to provide quality leadership across new product development, design validation, risk management, and product launch activities.
Work Flexibility:
Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.
What You Will Do
- Lead quality engineering activities for new product development programs, ensuring compliance with applicable quality system and regulatory requirements.
- Guide development teams through design controls, risk management, verification, validation, and product launch processes.
- Conduct and maintain risk management activities, including risk assessments, risk analyses, and implementation of mitigation strategies throughout product development.
- Lead human factors engineering activities to support the development of safe, intuitive, and user-focused products.
- Plan, execute, and approve design validation activities to verify products meet defined user needs and intended use requirements.
- Support process validation activities and establish quality controls that enable consistent manufacturing performance and long-term product quality.
- Develop inspection methods and procedures for incoming materials, in-process controls, and finished products to ensure compliance with product specifications.
- Review technical deliverables, investigate nonconformances and corrective actions, perform root cause analysis, and provide quality representation during cross-functional project reviews.
What You Will Need
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
- Minimum 4 years of experience in a Quality Engineering or Technical Engineering role within a research and development or manufacturing environment.
- Experience supporting quality activities within a regulated industry environment.
- Experience supporting product development, design quality, design controls, or new product introduction activities.
Preferred Qualifications
- Working knowledge of ISO 13485, ISO14971, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
- Minimum 3 years of experience as an Advanced Quality Engineer, Design Quality Engineer, or equivalent role.
- Experience in the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industry.
- ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), GD&T certification, or equivalent professional certification.
$89,300 - $148,800 USD Annual
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.
Frequently Asked Questions
What is the salary for the Staff Advanced Quality Engineer role at stryker?
The listed salary for this Staff Advanced Quality Engineer position at stryker is USD 89K–149K. This is an Full time role.
Where is the Staff Advanced Quality Engineer position at stryker located?
This Staff Advanced Quality Engineer role at stryker is based in Portage, Michigan. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Staff Advanced Quality Engineer role at stryker full-time or part-time?
This is listed as a Full time position. It is posted as a Staff Advanced Quality Engineer role in the Stryker Employment Company, LLC department at stryker.
Which team or department does the Staff Advanced Quality Engineer at stryker belong to?
This Staff Advanced Quality Engineer position is part of the Stryker Employment Company, LLC department at stryker. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Staff Advanced Quality Engineer position at stryker?
Click the "Apply Now" button on this page. You will be redirected to stryker's official application portal hosted on workday where you can submit your application directly.
When was the Staff Advanced Quality Engineer job at stryker posted?
This Staff Advanced Quality Engineer position at stryker was posted on Aug 11, 2026. Apply as soon as possible — early applications are often reviewed first.
Staff Advanced Quality Engineer
stryker · 💰 USD 89K–149K
You'll be redirected to stryker's official application page on Workday.