Senior Quality Engineer, Medical Instruments (Onsite)

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

Job summary

Stryker is seeking a Senior Quality Engineer in Kalamazoo, MI to develop and implement methods for process control, testing, and inspection across the product lifecycle. You will work with operations, engineering, and suppliers to impact product quality and manufacturing control.

The role requires a Bachelor’s degree in engineering or science and at least 2 years in quality within a regulated industry, with preference for medical device regulatory experience and RCA/ CAPA leadership.

Qualifications

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

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention in manufacturing operations.
• Investigate internal and supplier-related nonconformances, lead root cause analyses, and manage corrective and preventive actions.
• Review, disposition, and document nonconforming product through material review processes, including containment.
• Analyze quality data and KPIs, identify trends, and address risks.
• Evaluate manufacturing and supplier changes for quality and risk impacts before implementation.
• Support supplier quality improvement activities and performance monitoring.
• Apply statistical methods and risk management to support process capability, inspection strategies, and sampling plans.
• Support audits, manufacturing transfers, engineering changes, and field-quality investigations.

Skills

Quality engineering

Regulatory

Root cause analysis

Process improvement

Risk management

Supplier quality

Statistical methods

Education

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

Job description

Stryker is seeking a Senior Quality Engineer in Kalamazoo, MI to develop and implement methods for process control, testing, and inspection across the product lifecycle. You will work with operations, engineering, and suppliers to impact product quality and manufacturing control.

The role requires a Bachelor’s degree in engineering or science and at least 2 years in quality within a regulated industry, with preference for medical device regulatory experience and RCA/ CAPA leadership.