Customer Quality Engineer - Hybrid
StrykerAbout the role
Customer Quality Engineer – Hybrid
Stryker is hiring a Customer Quality Engineer in Cary, IL. As a Customer Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes through the post market system. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards
Work Flexibility: Hybrid.
The candidate must reside within a commutable distance to Cary, IL and is expected to be onsite at the facility multiple times/week.
Who we want
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
- Complaint Management: Investigate and resolve customer complaints and product field actions, ensuring timely closure and exceptional service.
- Cross-Functional Collaboration: Work with customers, sales, marketing, and other teams to address and resolve top quality issues.
- Root Cause Analysis: Lead NC/CAPA/CHS processes, focusing on problem-solving and identifying root causes of quality issues.
- Quality Monitoring: Maintain and analyze KPIs to monitor product and process quality, interpret trends, and take corrective actions as needed.
- Risk and Statistical Analysis: Develop risk management strategies and apply statistical methods (e.g., SPC, DOE) to support quality initiatives.
- Audit Support: Participate in internal and external audits, providing expertise and preparing necessary documentation to ensure compliance.
- Continuous Improvement: Identify and implement opportunities for quality system enhancements and support ECO & CAPA processes to enforce compliance.
- Reliability Enhancement: Trend and analyze complaints to identify major product issues, driving initiatives to improve product reliability and performance.
What you need
Basic Qualifications:
- Bachelor’s Degree in Engineering, Science or related field
Preferred Qualifications:
- Ability to conduct and document technical investigation
- Experience with GD&T and Statistical Analysis Capability
- Experience in a cGMP regulated pharmaceutical or medical device environment (specifically 21CFR211 and 21CFR820)
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