Principal Supplier Quality Engineer - Maple Grove, United States - Boston Scientific

Description

Recruiter: Spencer Gregory Hale

Principal Supplier Quality Engineer

About the role:
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 Principal Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes.

This is a hybrid role with the expectation to be in the office 2 days a week. This position will be located in Maple Grove, MN.

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 audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

New Product Development:

• 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, 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.

Minimum qualifications:

• BS degree in engineering or technical field with 9 years or MS degree and 7 years relevant experience.
• Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: the ability to influence cross-functional global teams spanning quality, operations, R&D, and sourcing.
• Experienced in Problem Solving methodologies; including the ability to lead multifaceted investigations across complex supply chains.
• Experience in process validation, design controls, risk management, and CAPA.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred qualifications:

• Ability to work independently; organized and self-driven.
• Articulate communicator adept at packaging and appropriately scaling information to the intended audience.
• 7+ years of medical device engineering experience.
• Experience with catheter design and/or manufacturing.
• Previous support for high volume manufacturing.
• 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) strongly desired.
• Fluent in Spanish

Requisition ID: 579500

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.