Supplier Quality Engineer III - Endoscopy SFMD

bostonscientific•Marlborough, MA

1d•$79,700 - $151,400

About The Position

The Sourced Finished Medical Device (SFMD) Supplier Quality Engineering organization at Boston Scientific is a global team that oversees a diverse network of suppliers which manufacture finished devices for distribution. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets our customer’s expectations.

Requirements

BS degree in engineering or technical field.
3+ years of quality engineering experience within med device (or 4+ years of quality engineering experience within a different regulated industry).
Experience in medical device, automotive, aeronautical, or other regulated industry.
Ability to communicate effectively, and concisely package information to deliver key points; appropriately scale communication style and depth according to the audience.
Ability to work independently; organized and self-driven.
Ability to rapidly learn and use new software applications (e.g., ERP, PLM).
Domestic and international travel up to 25%.

Nice To Haves

Ability to influence cross functional global teams spanning Supplier Management, Quality, Operations, R&D, Design Assurance, and Sourcing.
Experience in process validation, design controls, risk management, and CAPA.
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.

Responsibilities

Proactively identifies and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
Review and approve supplier corrective action plans and verification of effectiveness documentation.
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.
Tracks and trends supplier performance and provides key quality trending information and data for Management Review and Complaint Reviews.
Support the execution of SFMD Quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers and innovative medical devices.
Generate/review quality plans, agreements, product specifications, component qualifications, and process validations.
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.