Quality Assurance Engineer
hace 2 días
As a Quality Assurance Engineer at Boston Scientific Corporation, you will play a crucial role in ensuring the highest quality standards for our medical devices. This is an exciting opportunity to join a dynamic team of professionals who share your passion for quality and innovation.
About the Role
The successful candidate will be responsible for providing Quality Engineering support to commercial and development products, ensuring delivery of high-quality results to our customers. This includes collaborating with R&D, Post Market, Manufacturing Engineers, and product development teams to develop robust new products. You will work on design activities, risk management, post-market surveillance, and CAPA initiatives, including process validation and verification, technical drawing reviews, and project participation to identify root causes and implement corrective actions.
Your Responsibilities Will Include:
- Performing process validation and verification activities and reviewing related documentation
- Supporting other functional areas during validation activities
- Reviewing and approving technical drawings, procedures, and protocols
- Participating in projects to identify root cause and implement corrective and preventive actions
- Responsible for investigating nonconformances and writing required documentation
- Responsible for completing signal evaluations for assigned product areas
- Understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems
Required Skills and Qualifications
To succeed in this role, you will need:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field
- English language proficiency level B2 (70-79%)
- At least 1 year of experience in the current position
Preferred Qualifications
A strong background in quality systems and good documentation practices, experience in the medical device industry, and self-starter skills with the ability to identify improvement opportunities are highly desirable. Proficiency in Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and Outlook, as well as familiarity with product documentation, inspection, and testing, are also essential. Knowledge of inspection techniques and statistical methods, scientific tools, such as Gage R&R, DOE, and process capability, is a plus.
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