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Supplier Quality Engineer I Job

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Date: Jul 19, 2019

Location: Marlborough, MN, US, 01752

Company: Boston Scientific

 

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

 

About This Role:

The Supplier Quality Engineer I will play an integral part in contributing to the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scientific’s requirements. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal resources to ensure a level of quality that exceeds our customer’s expectations.

 

 

Your Responsibilities Will Include:

Sustaining:

  • Tracks and trends supplier performance and provides key quality trending information and data for Management Review and Complaint Reviews.
  • 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.
  • Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
  • Provides support to lead auditors to assess our supplier’s compliance with regulatory and Boston Scientific requirements, including audit scheduling, evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

New Product Development:

  • Provide support in completing SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • Generate/review quality plans, agreements, product specifications, component qualifications, and process validations.

Quality System Champion:

  • Champions 100% compliance to company policies and SOP’s.
  • Identifies and advises management on potential improvements to quality systems and processes in the company.

 

 

What  We’re Looking For In You

Minimum Qualifications:

  • Bachelor of Science in engineering or related technical field.
  • Ability to work independently; organized and self-driven.
  • Ability to rapidly learn and use new software applications (e.g., SAP, PLM).
  • Strong command of MS Office – Word, Excel, PowerPoint, and Visio.
  • Domestic and international travel (up to 25%).

Preferred Qualifications:

  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Working knowledge of Quality Management Systems (e.g., ISO 9001, ISO 13485) and medical device regulations (e.g., 21 CFR 820, MDD).
  • ASQ certification (e.g., Lead Auditor, CQE, SSGB, SSBB) strongly desired.

 

 

 

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 447838

 


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