Staff Quality Engineer - Service

Work Flexibility: Onsite

Stryker is hiring a Staff Quality Engineer - Service for our Instruments division. This is an onsite role based 5 days per week in Kalamazoo, MI. 

 

As the Staff Quality Engineer - Service you will focus on developing and standardizing inspection documentation to support product quality, compliance, and operational efficiency. You will partner across engineering, quality, and operations to translate complex requirements into practical, usable documentation.

 

What you will do

• Lead development and standardization of inspection plans, work instructions, and acceptance criteria across product lines.

• Evaluate current inspection processes and documentation to identify gaps, inconsistencies, and improvement opportunities.

• Translate engineering drawings, specifications, and regulatory requirements into clear and accurate inspection documentation.

• Collaborate with cross-functional teams to gather requirements and align documentation with operational needs.

• Facilitate document reviews, approvals, and implementation to ensure timely adoption and compliance.

• Ensure all documentation aligns with regulatory standards, including FDA requirements and ISO 13485.

• Develop templates and best practices to improve efficiency and consistency across inspection processes.

• Manage project timelines, deliverables, and stakeholder updates to ensure completion within defined schedules.

What you need

 

Required

• Bachelor’s degree in Engineering or a related technical discipline.

• 4+ years of experience in quality engineering, manufacturing engineering, or quality systems within a regulated industry.

• Experience developing technical documentation such as inspection plans, work instructions, or quality procedures.

• Knowledge of quality inspection methods, measurement systems, and quality control principles.

Preferred

• Experience in medical device development or manufacturing.

• Knowledge of FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices.

• Experience using document control systems or quality management systems.

• Professional certification (e.g., Certified Quality Engineer, Six Sigma Green Belt or higher).

  

 

• USN: $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.