Supplier Quality Engineer II - Endoscopy SFMD
Boston Scientific · Marlboro, MA
- Level
- Engineer
- Team
- Quality
- Travel
- 25%
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 18 days ago
The role in 30 seconds
An engineer-level quality role at Boston Scientific (medical devices) in Marlboro, MA. Generate/review quality plans, agreements, product specifications, component qualifications, and process validations.
- They ask for
- 2+ years · degree required
- Tools it names
- CAPA, ISO 13485, Validation (IQ/OQ/PQ), Internal audits, Supplier quality
- Day to day
- about 25% travel
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About the role
About the role
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.
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. .
- ✓Experience in process validation, design controls, risk management, and CAPA.
- ✓Lead auditor of quality systems experience (ISO 13485 or similar).
- ✓ASQ certification (CQE, SSGB, SSBB) desired.
Minimum Salary: $ 75100
Maximum Salary: $ 142600
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.
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Recruiter: Spencer Gregory Hale
Supplier Quality Engineer II – Endoscopy SFMD
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.