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Medical Device Quality Specialist
hace 7 días
We're seeking an experienced Quality Assurance Engineer to join our team at Boston Scientific Corporation. As a key member of our Quality Engineering group, you will be responsible for ensuring that our medical devices meet the highest quality standards. This is a unique opportunity to work with a talented team of professionals who share your passion for quality and innovation.
About the Job
This role involves providing Quality Engineering support to commercial and development products, ensuring delivery of high-quality results to our customers. You will work closely with R&D, Post Market, Manufacturing Engineers, and product development teams to develop robust new products. Your responsibilities will include performing process validation and verification, reviewing technical drawings, participating in projects to identify root causes, and implementing corrective actions. Additionally, you will investigate nonconformances, complete signal evaluations, and understand product quality plans and systems.
Your Key Responsibilities
- Providing Quality Engineering support to commercial and development products
- Collaborating with R&D, Post Market, Manufacturing Engineers, and product development teams
- Performing process validation and verification activities
- Reviewing technical drawings and procedures
- Participating in projects to identify root causes and implement corrective actions
- Investigating nonconformances and writing required documentation
- Completing signal evaluations for assigned product areas
- Understanding product quality plans and systems
Requirements
To succeed in this role, you should have a Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field, English language proficiency level B2 (70-79%), and at least 1 year of experience in the current position. Preferred qualifications include knowledge of basic Quality System and good documentation practices, experience in medical device industry, and self-starter skills with the ability to identify improvement opportunities.
