Senior Engineer, Quality

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

• Bachelors 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: $77700 - $129500 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 contractors legal duty to furnish information.