Senior Supplier Quality Engineer Direct Materials Acquisitions

SeniorSupplier Quality EngineerDirect Materials Acquisitions

Onsite/Hybrid Location(s):Marlborough MA; MinneapolisMN;

About the role:
The Global Sourcing organization at Boston Scientific is a global passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Global Sourcing organization at Boston Scientific is a global passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our suppliers manufacturing this role you will support products within the acquisition space with a primary focus on components.

Your responsibilities include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound systematic problem-solving methodologies inidentifying prioritizing and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.

• Manages sustaining quality issues process change impacts and design change implementations for suppliers within the Acquired Entity Quality system the hybridized BSC-Acquired Entity Quality System and in the BSC Quality System after products are successfully integrated.

• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.

• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements including audit scheduling investigation and evaluation of audit observation and findings reporting follow-up and confirmation of follow-up actions.

• SupportsDesign Quality Assurance withField Action and Product Inquiry Reports byperforming investigations on supplier-related or supplier-caused quality issues.

• Investigates complaintsand manages NCEPsat OEM suppliers andCM suppliers where the issue ismanufacturing-related.

• Supports Supplier Change Impact Assessments for process changes at suppliers.

• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.

• Leadsprojects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part ofprojectplanning process.

New Product Development:

• Support manufacturing lines ofacquiredentitys manufacturing line throughintegration ofacquiredcompanys suppliers and products into BSCs Quality System.

• Leadthe execution ofmaterialcontrolsquality deliverables and collaborate with cross-functional new product development teams to onboard suppliers.

• Generate and review quality plans agreements product specificationscomponentqualifications design verification/validations and process validations.

Quality System Champion:

• Supports Material Controls external regulatory body audits requests asrequired.

• Leads or supports Material Controls internal audit efforts.

• Collaborates with corporate and regionalsupplierquality organizations on policy procedure and guideline development. Includes generation review and implementation of these documents.

• Identifiesandadvisesmanagement on potential improvements to quality systems and processes in the company.

• Champions 100% compliance to company policies andSOPs.

Whatwerelooking for in you:
Minimal Qualifications:

• BS degree in engineering or technical fieldwithminimum of5years of relevant experience.

• Experience in medicaldevice automotive aeronauticalsemiconductor or other regulatedindustry.

• Project management: ability to influence cross functional global teams spanning Quality Operations R&D and Sourcing.

• Experience in process validation design controls risk management CAPA SCAR.

• Ability to work independently; organized and self-driven.

• Articulatecommunicator;adept at packaging and appropriately scaling information to the intended audience.

• Ability to rapidly learn and use new software applications (e.g. PLM ERP).

• Domestic and international travelupto25%.

Preferred Qualifications:

• 7 years of medical device engineering experience preferred.

• Medical Device Industry experience

• Drug or animal tissue experience

• ProblemSolving and Project Management experience

• Leadership experienceona materials or service commodity team.

• Lead auditor of quality systems experience (ISO 13485 or similar).

• ASQ certification (CQE CBA SSGB SSBB)desired.