Staff Quality Engineer

Regulatory Jobs; Kalamazoo (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers in Surgical Technologies. You will focus on quality assurance, process control, risk prevention, and continuous improvement of products and processes on site.

You will lead CAPA activities, investigations, and PPAP readiness, while collaborating with operations, engineering, supplier, and quality teams to ensure product and process

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.

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 timely containment, root cause analysis, corrective actions, and record closure.
• Lead and support CAPA activities, including investigation, implementation, and effectiveness verification.
• Review and disposition nonconforming materials while supporting material review and quality decision-making processes.
• Execute PPAP activities and support manufacturing readiness for product and process changes.
• Support process validation, equipment qualification, MSA, and risk management activities.
• Monitor quality metrics, analyze trends using statistical methods and process control tools, and drive continuous improvement initiatives.

Skills

Quality mindset

Cross-functional collaboration

Regulated environment experience

Process improvement

Six Sigma belt

Education

Bachelor's degree in Engineering/Science

Tools

SPC

MSA

PPAP

CAPA

GD&T

ISO 13485

GMP

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

View the U.S. work location and transparency guide to find the pay range for your location.

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.