Senior Quality Engineer

Stryker; Kalamazoo (MI); On-site; USD 77,700 - 129,500; Full time

Benefits offered by this job

Medical and prescription drug insurance

Dental insurance

Vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in Kalamazoo, MI is hiring a Senior Quality Engineer to develop and implement quality methods for manufacturing. You'll investigate nonconformances and manage corrective actions, ensuring products meet quality standards. The ideal candidate will have a Bachelor's degree in Engineering or related field with at least 2 years experience in quality within a regulated industry. This role offers a competitive salary and comprehensive health and financial benefits.

Qualifications

• Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated industry.
• Experience working with U.S. and international medical device regulatory requirements.
• Experience managing nonconformance investigations and corrective action activities.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing.
• Investigate nonconformances and lead root cause analysis.
• Support supplier quality improvement activities.

Skills

Quality methods for process control

Root cause analysis

Statistical methods

Risk management practices

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

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 2 years of experience in quality, manufacturing, or engineering 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 driving manufacturing process improvements in a regulated environment
• Experience applying risk management and statistical process control methods in manufacturing environments

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

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. 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.