Staff Quality Engineer

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

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches, manufacturing transfers, and supplier quality initiatives. You will drive CAPA, PPAP, process validation, and risk management activities across life cycles and ensure regulatory compliance.

The role emphasizes cross-functional teamwork with operations, engineering, and suppliers, plus responsibilities for nonconformance investigations and trend analysis using

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field.
• 4+ years in quality engineering, manufacturing quality, supplier quality, or related role.
• Experience leading or supporting cross-functional quality projects in a regulated environment.

Responsibilities

• Support quality deliverables for new product launches, manufacturing transfers, supplier changes, and engineering change initiatives.
• Partner with operations, engineering, supplier, and quality teams to ensure product and process quality performance.
• Own nonconformance investigations and drive containment, root cause analysis, correct actions, and record closure.
• Lead CAPA activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials; support material review and quality decisions.
• Execute PPAP activities and support manufacturing readiness for changes.
• Support process validation, equipment qualification, MSA, and risk management.
• Monitor quality metrics, analyze trends using statistical methods and process control tools.

Skills

Quality Engineering

Project Leadership

Regulatory Compliance

CAPA Management

Education

Bachelor's degree in Engineering

Tools

SPC

MSA

CMMs

GD&T

Job description

Work Flexibility: Onsite As a Staff Quality Engineer in Kalamazoo MI, you will provide quality engineering support for quality deliverables related to new product launches and manufacturing transfers for Surgical Technologies. This includes supporting projects throughout the full lifecycle, as well as post-handoff manufacturing sustainment activities, with a focus on quality assurance, process control, risk prevention, and continuous improvement of products and manufacturing processes. Additionally, you will support supplier quality issues that impact projects, lead initiatives to enhance product and process quality, and ensure compliance with applicable regulatory requirements and quality standards.

What You Will Do

• Support quality deliverables for new product launches, manufacturing transfers, supplier changes, and engineering change initiatives.
• Partner with operations, engineering, supplier, and quality teams to ensure product and process quality performance.
• Own nonconformance investigations and drive timely containment, root cause analysis, corrective actions, and record closure.
• Lead and support Corrective and Preventive Action (CAPA) activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
• Execute Production Part Approval Process (PPAP) activities and support manufacturing readiness for product and process changes.
• Support process validation, equipment qualification, measurement system analysis (MSA), and risk management activities.
• Monitor quality metrics, analyze trends using statistical methods and process control tools, and drive continuous improvement initiatives.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or a related quality-focused engineering role
• Experience leading or supporting cross-functional quality projects, including new product launches, manufacturing transfers, process improvements, or engineering change initiatives in a regulated environment.

Preferred Qualifications

• Experience with quality systems, including nonconformance management, CAPA, audits, and risk management.
• Experience supporting process validation, equipment qualification, PPAP, and measurement system analysis (MSA).
• Familiarity with statistical process control (SPC), data analysis, and quality improvement methodologies.
• Familiarity with geometric dimensioning and tolerancing (GD&T).
• Experience using metrology equipment such as calipers, micrometers, pin gauges, and coordinate measuring machines (CMMs).
• Familiarity with ISO 13485 and Good Manufacturing Practice (GMP) requirements.
• Six Sigma Green Belt or Black Belt certification.

United States of America Pay Ranges: USN: $89,300 - $148,800 USD Annual

Travel Percentage: 20%

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.