Senior Supplier Quality Engineer - Direct Materials Acquisitions
About The Position
The Senior Supplier Quality Engineer is part of Boston Scientific’s Global Sourcing organization, which oversees a global network of suppliers manufacturing components and finished devices. The role supports products in the acquisitions space, primarily components and applicable accessories, and maintains a primary commitment to patient safety. It works with internal and external cross-functional partners to improve supplier manufacturing processes. The position manages supplier and sustaining quality issues, process and design changes, supplier audits, investigations, and supplier corrective actions. It also supports integration of acquired companies’ suppliers and products into Boston Scientific’s Quality System, supplier onboarding and new product development quality deliverables, and quality-system improvements and compliance. The role requires domestic and international travel of up to 25%. It is designated safety-sensitive, and candidates are subject to prohibited substance testing.
Requirements
- Bachelor of Science degree in engineering or a technical field and at least 5 years of relevant experience.
- Experience in medical device, automotive, aeronautical, semiconductor, or another regulated industry.
- Project management skills and ability to influence cross-functional global teams spanning Quality, Operations, R&D, and Sourcing.
- Experience with process validation, design controls, risk management, CAPA, and SCAR.
- Ability to work independently; organized and self-driven.
- Articulate communication skills, including the ability to tailor and scale information to the intended audience.
- Ability to rapidly learn and use software applications such as PLM and ERP.
- Ability to travel domestically and internationally up to 25%.
Nice To Haves
- 7 or more years of medical device engineering experience.
- Medical device industry experience.
- Drug or animal tissue experience.
- Problem-solving and project-management experience.
- Leadership experience on a materials or service commodity team.
- Lead auditor experience with quality systems such as ISO 13485.
- ASQ certification such as CQE, CBA, SSGB, or SSBB.
Responsibilities
- Evaluate and communicate quality issues to suppliers, use systematic problem-solving methods to identify and resolve issues, and review supplier corrective action plans and verification-of-effectiveness documentation.
- Manage sustaining quality issues, process-change impacts, and design-change implementations across acquired-entity, hybridized BSC-acquired-entity, and BSC quality systems as products are integrated.
- Assess supplier capabilities through on-site visits and technical discussions, and coordinate evaluation of proposed supplier changes.
- Plan and lead supplier audits for regulatory and Boston Scientific requirements, including scheduling, investigation and evaluation of findings, reporting, follow-up, and confirmation of follow-up actions.
- Support Design Quality Assurance field actions and Product Inquiry Reports by investigating supplier-related or supplier-caused quality issues.
- Investigate complaints and manage SCARs/NCEPs at component suppliers when issues are manufacturing-related.
- Support supplier change impact assessments for supplier process changes.
- Support and perform finished-good documentation changes for design changes or labeling updates.
- Lead projects, meet milestones, create clear project plans, and develop contingency plans.
- Support acquired-entity manufacturing lines by integrating acquired-company suppliers and products into Boston Scientific’s Quality System.
- Lead execution of material-controls quality deliverables and collaborate with cross-functional new product development teams to onboard suppliers.
- Generate and review quality plans, agreements, product specifications, component qualifications, design verification and validations, and process validations.
- Support Material Controls requests for external regulatory body audits and lead or support Material Controls internal audits.
- Collaborate with corporate and regional supplier quality organizations to develop, review, and implement policies, procedures, and guidelines.
- Identify and advise management on potential quality-system and process improvements.
- Champion full compliance with company policies and standard operating procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
