Senior Quality Engineer

Stryker Corporation; Kalamazoo (MI); On-site; USD 101,000 - 137,000; Full time

Job summary

Stryker Corporation is seeking a Senior Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. You will partner with operations, engineering, suppliers, and quality teams to drive compliance and resolve quality issues, and support new product introductions and scale-up.

You will lead or participate in investigations, CAPAs, and supplier quality initiatives while monitoring quality metrics and driving continuous improvement.

Qualifications

• 2+ years of quality engineering, manufacturing engineering, or related experience.
• Experience supporting non-conformance investigations and CAPA, or quality management systems.
• Experience in the medical device industry is preferred.

Responsibilities

• Monitor and improve product and process quality performance.
• Assist transfer, launch, and scale-up of new products and processes.
• Lead investigations and closure of non-conformances and CAPAs.

Skills

Quality engineering

Manufacturing experience

Education

Bachelor's degree

Tools

GD&T

CMMs

Calipers

Micrometers

Job description

Work Flexibility: Onsite Stryker is seeking a Senior Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. In this role, you will partner with operations, engineering, suppliers, and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale up activities, lead continuous improvement initiatives, and ensure products meet applicable regulatory and quality requirements.

What You Will Do

• Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.
• Support the transfer, launch, and scale-up of new products and manufacturing processes, partnering cross-functionally to establish robust quality systems and ensure successful production readiness.
• Support or lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and implementation of corrective actions.
• Review and disposition nonconforming materials and products through Material Review Board processes.
• Collaborate with suppliers to address quality issues, manage supplier corrective actions, and support supplier quality improvement initiatives.
• Evaluate and support manufacturing, supplier, and engineering changes to ensure compliance with quality and regulatory requirements.
• Monitor quality performance indicators, analyze trends, and implement actions to address identified risks and improvement opportunities.
• Support continuous improvement initiatives focused on quality enhancement, scrap reduction, efficiency gains, and cost savings.
• Support process validation, equipment qualification, inspection methods, measurement system analysis, and statistical process controls.
• Participate in internal and external audits, complaint investigations, field actions, and continuous improvement projects across manufacturing operations.

What You Will Need

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of quality engineering, manufacturing engineering, or related engineering experience.
• Experience supporting non-conformance investigations, corrective and preventive actions, or quality management systems.

Preferred Qualifications

• Experience in the medical device industry.
• Experience analyzing quality data and applying statistical methods to support manufacturing or process improvements.
• Six Sigma Green Belt or Six Sigma Black Belt certification.
• Experience with geometric dimensioning and tolerancing (GD&T).
• Experience using metrology equipment such as calipers, micrometers, pin gauges, or coordinate measuring machines (CMMs).

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.

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.