Supplier Quality Engineer II - Endoscopy SFMD at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Medical Device, Problem-Solving, Supplier Management, Process Validation, Design Controls, Risk Management, CAPA, Communication, Software Applications, Leadership, Auditing, ISO 13485, Technical Discussions, Cross-Functional Collaboration, Data Analysis

Industry

Medical Equipment Manufacturing

Description

Sustaining Engineering: 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. 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. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. BS degree in engineering or technical field. 2+ years of quality engineering experience within med device (or 3+ 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%. Ability to influence cross functional global teams spanning Supplier Management, Quality, Operations, R&D, Design Assurance, and Sourcing. 3+ years of medical device engineering experience preferred. 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

The Supplier Quality Engineer II proactively identifies and communicates quality issues to suppliers while applying systematic problem-solving methodologies. They review and approve supplier corrective action plans, assess supplier capabilities, and track supplier performance.