Advanced Quality Engineer at Stryker
Overview
You will own quality assurance for new product development on the Sustainability Solutions team, ensuring cutting-edge medical device technology is safe, effective, and compliant. You will collaborate with R&D, Marketing, Advanced Operations, and Regulatory Affairs to meet product development metrics. This hybrid role blends traditional R&D Engineering with Quality Engineering, using advanced statistical techniques for test sample sizing. You will drive risk management and design control for reprocessing product lines, impacting patients worldwide.
What You'll Do6
- 1Represent Quality Assurance on new product development cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
- 2Build and implement Risk Management Files, identifying hazards and ensuring compliance with corporate and local design control procedures.
- 3Design and implement inspection, testing, and evaluation methods to ensure product reliability, applying advanced statistical techniques for test sample size determinations.
- 4Drive Design Reviews to ensure design and process robustness, compliance with QSR and ISO 13485, and proper risk analysis for new medical devices.
- 5Plan and execute engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
- 6Interact with customers to address product quality concerns, provide training on GMP topics, and support continuous improvement initiatives.
Requirements5
- 1Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Material Science, Biomedical Engineering or related science or engineering discipline.
- 2Experience in data collection, data analysis, and scientific method.
- 3Experience with Risk Management, CAPA, Audits, and Statistics.
- 4Previous medical device industry experience preferred.
- 5Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, and GMP.
Salary Insight
$76 - $122k per year
Location
Required Skills
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