Supplier Quality Engineer II - SFMD Neuromodulation

Boston Scientific•Maple Grove, MN

9d•$71,500 - $135,800

About The Position

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support SFMD products associated with the Nalu acquisition associated with the Neuromodulation division. Your responsibilities include: Sustaining Engineering: Evaluates and communicates quality issues to suppliers and 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. 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. Manages sustaining quality issues, process change impacts, and design change implementations for the supplier, Nalu. Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues. Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-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. Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process. New Product Development: Execute SFMD Plan deliverables for launch of Nalu’s products into BSC’s Quality System. Support 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, and process validations. Quality System Champion: 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.

Requirements

BS degree in engineering or technical field with minimum of 2 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
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)
Domestic and international travel up to 25%

Nice To Haves

3+ years of medical device engineering experience preferred
Medical Device Industry experience
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, CBA, SSGB, SSBB) desired

Responsibilities

Evaluates and communicates quality issues to suppliers
Reviews and approves supplier corrective action plans
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
Manages sustaining quality issues, process change impacts, and design change implementations for the supplier, Nalu
Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers
Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues
Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-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
Supports projects and contributes to consistently hitting project milestones
Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process
Execute SFMD Plan deliverables for launch of Nalu’s products into BSC’s Quality System
Support 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, and process validations
Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development
Identifies and advises management on potential improvements to quality systems and processes in the company
Champions 100% compliance to company policies and SOP’s