Senior Quality Engineer

Stryker; Kalamazoo (MI); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Wellbeing program

Job summary

Stryker in Kalamazoo, MI is seeking a Senior Quality Engineer to develop and implement quality methods across manufacturing. You will lead root cause analyses, manage corrective actions, and collaborate with operations, engineering, and suppliers to ensure product quality and regulatory compliance.

The role emphasizes process control, data analysis, and risk assessment to support product lifecycle quality improvements and supplier performance enhancements.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum 2 years of quality engineering experience within a regulated industry.
• Experience with medical device regulatory requirements is preferred.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations.
• Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage corrective and preventive actions.
• Review and disposition nonconforming product through material review processes, including containment and escalation.
• Analyze quality data and KPIs, identify trends, and initiate actions to address risks.
• Evaluate manufacturing and supplier changes for quality and risk impact prior to implementation.
• Support supplier quality improvement activities and ongoing performance monitoring.
• Apply statistical methods and risk management to support process capability and sampling plans.
• Assist audits, transfers, engineering changes, and field quality investigations as a SME.
• Collaborate with manufacturing and engineering to resolve production quality issues.

Skills

Quality engineering experience

Regulated industry exposure

Education

Bachelor’s degree in Engineering, Science, or a related technical field

Job description

At Stryker, our quality engineers play a critical role in ensuring products consistently meet defined quality and regulatory requirements.

We are hiring a Senior Quality Engineer in Kalamazoo, MI supporting Instruments! In this role, you will develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products function as designed and meet established quality standards. You will work closely with operations, engineering, and suppliers, with direct impact across product quality, supplier performance, and manufacturing process control throughout the product lifecycle.

What You Will Do

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations
• Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirements
• Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation when required
• Analyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risks
• Evaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementation
• Support supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoring
• Apply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plans
• Support internal and external audits, manufacturing transfers, engineering changes, and field-related quality investigations as a subject matter resource
• Collaborate closely with manufacturing and engineering teams to identify, investigate, and resolve quality issues impacting production

Required Qualifications

What You Will Need

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 2 years of quality engineering or related quality experience within a regulated industry

Preferred Qualifications

• Experience working with U.S. and international medical device regulatory requirements
• Experience managing nonconformance investigations and corrective action activities in a regulated quality system
• Experience supporting supplier quality activities or manufacturing process improvements
• Experience applying risk management and statistical process control methods in manufacturing environments

United States of America Pay Ranges:

USN: $77,700 - $129,500 USD Annual

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

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.