Quality Assurance Engineer (Onsite)
Stryker•Flower Mound, TX
•Onsite
About The Position
Stryker is hiring a Quality Assurance Engineer for our Global Quality Operations team in Flower Mound, Texas. This is an onsite position based in Stryker's Flower Mound office five days per week. As the Quality Assurance Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. You will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers, ensuring compliance to regulation and standards.
Requirements
- Bachelor’s degree in engineering
- Proficiency with standard computer applications
- Strong communication, project management, and influencing skills as well as the ability to manage multiple tasks simultaneously
Nice To Haves
- Familiarity with quality concepts such as risk management, corrective and preventive actions, and statistical analysis
- Knowledge of medical device regulations and standards, including ISO 13485 and Good Manufacturing Practices (GMP)
- Experience supporting audits or interacting with regulatory agencies (FDA, MoH, TUV, etc.)
Responsibilities
- Collaborate with operations and cross-functional teams to ensure product and process quality meets defined standards and specifications
- Review and approve nonconformance and corrective/preventive action records, ensuring timely closure and effectiveness tracking
- Analyze quality data and maintain key performance indicators to monitor trends, identify root causes, and reduce defects
- Support change management processes by evaluating quality impact and ensuring compliance with procedures
- Participate in internal and external audits, provide documentation, and address audit observations within required timelines
- Conduct risk assessments and support validation activities to ensure manufacturing processes meet regulatory and quality requirements
- Partner with engineering and commercial teams to investigate customer complaints and implement corrective actions
- Drive initiatives to improve inspection methods, reduce nonconformances, and enhance overall product quality performance
Benefits
- US10 : $76,500 - $122,000 USD Annual
- Travel Percentage: 10%
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
