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Advanced Quality Expert
2 weeks ago
Product Assurance Specialist
About the Role
We are seeking an experienced Quality Engineer to provide quality engineering support to our commercial and development manufacturing lines.
Key Responsibilities
- Process Improvement: Lead quality initiatives in value streams, focusing on process improvement and defect control.
- Troubleshooting: Investigate and analyze customer/internal complaints, developing technical investigation plans using Engineering Essentials.
- Compliance: Ensure regulatory compliance by utilizing quality tools and processes (PFMEA, Risk reduction, process change analysis).
- Qualification: Develop and review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), production control plans.
- Problem Solving: Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Requirements
- A bachelor's degree in Engineering, Quality, or Science with a minimum 2 years' experience in a Medical Device environment or related industry.
- Leadership Skills: Strong leadership and communication skills, promoting quality at source.
- Project Management: Project Management skills combined with proven consistent execution within committed quality, time, and cost targets.
About Us
Boston Scientific is a global medical device company committed to advancing science for life. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and create a better place for our employees to work and reflect the patients, customers, and communities we serve.
