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Why join Stryker?
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.
What You Will Need
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. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.
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