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Process and Product Validation Specialist
hace 3 semanas
**About Boston Scientific**
Boston Scientific Corporation is a global leader in medical technology, dedicated to developing innovative solutions that improve patient outcomes. Our company culture values diversity, innovation, and collaboration, providing employees with opportunities to grow and advance their careers.
We're seeking a skilled Process and Product Validation Specialist to join our team and contribute to the development of high-quality medical devices.
The successful candidate will be responsible for ensuring the quality of new products by reviewing and developing process validation protocols and reports, and validating attribute and/or variable in-process Test Methods (ATMs/VTMs).
The ideal candidate will have a strong understanding of quality principles, regulations, and industry standards, as well as excellent communication and problem-solving skills.
About the Role
- Review and develop process validation protocols and reports
- Validate attribute and/or variable in-process Test Methods (ATMs/VTMs) with Process Development and/or Manufacturing teams
- Support R&D and Process Development teams in the development of manufacturing processes and launch of new products to market
- Ensure compliance with ISO standards, cGMP's, Corporate and site level SOP's
Required Skills and Qualifications
- Bachelor's degree in Chemical, Materials, Electronic, Mechanical, Electromechanical Engineering or related field
- English Level: 80-89%
- Desired knowledge: ASQ certification (CQE, SSGB), formal studies in process & product validation, inspection techniques, and statistical methods
- At least 2 years of experience in a similar position or an equivalent combination of education and experience
