Supplier Quality Engineer III

Boston Scientific•Arden Hills, MN

18h•Hybrid

About The Position

The External Operations organization focuses on Sourced Finished Medical Device (SFMD) at Boston Scientific and is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer III will demonstrate a primary commitment to patient safety and compliance through collaboration with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes to ensure finished device quality. In this role, you will support SFMD products within the Electrophysiology division with a primary focus on Single-Use Devices and Capital Equipment. Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.

Requirements

Minimums of BS degree in engineering or technical field
Minimum of 5 years of relevant experience.
Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
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.
Domestic and international travel up to 25%.

Nice To Haves

3+ years of medical device engineering experience preferred.
Problem Solving and Project Management experience
Leadership experience on a materials or service commodity team.
Lead auditor of quality systems experience (ISO 13485 or similar).
ASQ certification (CQE, , SSGB, SSBB) desired
Ability to work independently; organized and self-driven.
Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
Ability to rapidly learn and use new software applications (e.g., PLM, ERP).

Responsibilities

Core team member to support product launch through execution of SFMD Plan deliverables for integration and/or onboarding of supplier and related products into BSC’s Quality System.
Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, process validations, and incoming inspection requirements.
Lead and support initial on-boarding assessments, new manufacturing locations and supplier’s approved status
Responsible for ongoing supplier qualification and performance monitoring based on supplier risk. Assess suppliers for technical, quality and manufacturing capabilities
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
Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.
Investigates & solves non-conformances due to product realization, product performance, incoming inspection, audit findings, & field failures related to supplier materials. Develop corrective action plan where necessary. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation
Supports supplier change impact assessments, process change impacts, and design change implementations for suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier’s Quality system.
Quality record ownership requiring technical writing skillset to formally document investigations, testing and verification of effectiveness actions utilizing statistical and industry standard quality tools
Supports Material Controls external regulatory body audits requests as required.
Leads or supports Material Controls internal audit efforts.
Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
Identifies and advises management on potential improvements to quality systems and processes in the company.
Champions 100% compliance to company policies and SOP’s.