Staff Advanced Quality Engineer

Stryker • Portage, MI

1d • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior