Senior Engineer, Quality

Stryker Corporation; Portage (MI); On-site; Confidential; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Quality Engineer to provide quality engineering across QA, QC, validation, risk management, and compliance to ensure products meet regulatory standards. You will support both existing products and new process initiatives within the Prime Stretcher manufacturing value stream, collaborating with operations, engineering, regulatory, and leadership teams.

This role emphasizes driving quality improvements, participating in audits, and applying

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated environment.
• Experience supporting validation activities in process, equipment, or system validation.
• Experience in the medical device industry.
• Experience with risk management tools such as FMEA or Fault Tree Analysis.
• Knowledge of statistical methods including sampling plans, process capability studies, and Gauge R&R.
• Experience in metal fabrication processes.

Responsibilities

• Review and approve validation and qualification documentation to ensure regulatory and internal compliance.
• Support CAPA, root cause investigations, and problem-solving activities.
• Review and approve manufacturing processes, equipment, and product changes via change management.
• Develop, execute, and analyze quality assessments, process qualifications, and validation activities.
• Apply risk management tools to identify and mitigate quality risks.
• Review and approve validation protocols and reports.
• Contribute to internal and external audits with subject matter expertise.
• Participate in Kaizen, Lean initiatives, and continuous improvement projects to boost product quality and efficiency.

Skills

Quality engineering

Regulated environment

FMEA

Gauge R&R

Statistical methods

Cross-functional collaboration

Metal fabrication

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Work Flexibility: Onsite Join Stryker as a Senior Quality Engineer in Portage, MI to support manufacturing operations, process validation, and continuous improvement activities. This role provides quality engineering expertise across quality assurance, quality control, validation, risk management, and compliance activities, helping ensure products and processes meet regulatory and quality standards. You will work cross-functionally with operations, engineering, and quality teams to support both existing products and new process initiatives. This role supports the Prime Stretcher manufacturing value stream, a highly visible product line, and offers the opportunity to drive meaningful quality improvements while partnering closely with operations, engineering, regulatory, and leadership teams.

What You Will Do

• Review and approve validation and qualification documentation to ensure compliance with regulatory requirements and internal procedures.
• Support quality activities related to nonconformances, corrective and preventive actions (CAPA), root cause investigations, and problem-solving efforts.
• Review and approve manufacturing processes, equipment, and product changes through established change management processes.
• Support the development, execution, and analysis of quality assessments, process qualifications, and validation activities.
• Apply risk management tools, including process risk assessments and failure analysis methodologies, to identify and mitigate quality risks.
• Review and approve process and equipment validation protocols, reports, and associated documentation.
• Participate in internal and external audits and provide subject matter expertise related to quality and validation activities.
• Participate in Kaizen events, Lean initiatives, and continuous improvement projects that enhance product quality, manufacturing efficiency, and operational performance.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated environment.

Preferred Qualifications

• Experience supporting validation activities, including process, equipment, or system validation.
• Experience within the medical device industry.
• Experience with risk management tools such as FMEA or Fault Tree Analysis.
• Knowledge of statistical methods including sampling plans, process capability studies, and Gauge R&R.
• Experience in working with Metal Fabrication processes.

USN: $77,700 - $129,500 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.

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.