Boston Scientific Supplier Quality Engineer II - Urology SFMD 

United States, Massachusetts, Marlborough 

501246034

Recruiter:Spencer Gregory Hale

Supplier Quality Engineer II – Urology SFMD

About the role:

Key responsibilities include:
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.

• 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.

New Product Development:

• 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.

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.

Qualifications:

Required qualifications:

• 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%.

Preferred qualifications:

• 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.

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.