Staff Quality Engineer

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

Benefits offered by this job

Health insurance

401(k) plan

ESPP

Job summary

Stryker in Kalamazoo, MI is seeking a Staff Quality Engineer to provide quality engineering support for new product launches and manufacturing transfers within Surgical Technologies. You will lead quality improvements, CAPA, PPAP, and risk management, partnering with cross-functional teams to assure compliance with regulatory standards and robust product quality throughout the lifecycle.

You will also support supplier quality issues, perform nonconformance investigations, and drive containment

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field is required.
• Minimum 4 years of experience in quality engineering, manufacturing quality, supplier quality, or related quality-focused engineering role.
• Experience leading or supporting cross-functional quality projects 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 containment, root cause analysis, corrective actions, and record closure.
• Lead CAPA activities, including investigation, implementation, and verification of effectiveness.
• Review and disposition nonconforming materials and support material review decisions.
• Execute PPAP activities and support manufacturing readiness for changes.
• Support process validation, equipment qualification, MSA, and risk management activities.
• Monitor quality metrics and use statistical tools to drive continuous improvement.

Skills

Quality engineering

Education

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

Tools

SPC

MSA

PPAP

CAPA

GD&T

CMMs

Job description

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.

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.

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.