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Sr Supplier Quality Engineer Job

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Date: Mar 11, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

 

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 the role:

The Senior Supplier Quality Engineer will play an integral part in leading 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 an acceptable level of quality.

What we’re looking for in you:

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.
  • 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.

     

    New Product Development:

  • Lead the execution of 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:

  • 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.

 

Basic Qualifications:

  • BS degree in engineering or technical field with minimum of 5 years of relevant experience.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
  • Experience in process validation, design controls, risk management, and CAPA.
  • 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 30%).

     

    Preferred Qualifications:

  • 7+ years of medical device engineering experience preferred.
  • Leadership experience on a materials or service commodity team.
  • Lead auditor of quality systems experience (ISO 13485, or similar).
  • ASQ certification (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: 441786

 


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