Diversity, Innovation and Caring for a Brighter Tomorrow
Boston Scientific is seeking a Supplier Quality Engineer P3 to join our global team.
Job Purpose:
The External Operations organization at Boston Scientific oversees a diverse network of suppliers that manufacture finished devices for BSC distribution. The External Operations Supplier Quality Management group manages sustaining activities for externally manufactured finished goods in the BSC Quality System.
Key Responsibilities:
1. Evaluate the quality performance of sourced finished medical device manufacturers (OEM and Contract Manufacturers).
2. Evaluate and communicate quality issues to suppliers and apply systematic problem-solving methodologies to identify, risk assess, prioritize, and resolve quality issues.
3. Investigate and solve non-conformances due to incoming inspection at BSC Distribution Centers.
4. Support the investigation of material quality issues/complaints and ensure adequate corrective actions are identified, implemented, and controlled by Suppliers.
5. Review and approve supplier corrective action plans and verify effectiveness documentation through SCAR ownership.
6. Plan and lead supplier assessments to assess compliance with regulatory standards and Boston Scientific requirements.
7. Collaborate with Supplier Engineering and Commercial Sourcing teams to support supplier management objectives in terms of Quality, Cost, and Service.
8. Sustain quality issues, process change impacts, and design change implementations for suppliers within their Quality system and in the BSC Quality System.
9. Participate in New Product Development projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.
Education and Experience:
1. A Level 8 Degree in an Engineering or Technical Discipline.
2. 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation, and CAPA.
3. Ability to work independently, organized, and self-driven.
4. A strong communicator who can effectively organize, present, and explain data/information with all internal and external stakeholders.
5. Competency in Microsoft software systems (e.g., MS Excel, PowerPoint, Power BI) and QMS software systems (CAPA, SCAR, etc.).
6. Domestic and international travel up to 25%.
Preferred Qualifications:
1. Prior experience within a quality function, preferably supplier quality.
2. Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.
3. Lead Assessor ISO13485 certification preferred.
4. Familiarity with Drug Coated products advantageous.