Senior Engineer, Quality

Stryker; Wisconsin; On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker is seeking a Senior Quality Engineer in Portage, MI to support manufacturing operations, process validation, and continuous improvement across QA, QC, validation, risk management, and compliance. You will collaborate with operations, engineering, regulatory, and leadership teams to improve product quality and manufacturing performance.

The role supports the Prime Stretcher manufacturing value stream, offering exposure to high-visibility initiatives and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 2+ years of experience in quality, manufacturing or engineering within a regulated environment.
• Experience with validation activities and risk management is preferred.

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 through change management.
• Develop, execute, and analyze quality assessments, process qualifications, and validation activities.
• Apply process risk assessments and failure analysis methods to identify quality risks.
• Review and approve validation protocols, reports, and related documentation.
• Participate in internal and external audits as subject matter experts in quality and validation.
• Engage in Kaizen events, Lean initiatives, and continuous improvement projects.

Skills

Quality engineering

Regulated environment

Process validation

Risk management

Statistical methods

Metal fabrication

Education

Bachelor’s degree in Engineering 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

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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.