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Quality Systems Engineer II Job

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Date: Jul 18, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific




Additional Locations: Ireland-Galway; US-MA-Marlborough; US-MN-Arden Hills




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 Engineer II - Quality Systems Engineer of material controls will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Specifically, this role will support the Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.



Your Responsibilities Will Include:

  • Participation in cross functional projects teams
    • Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines
    • Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements
    • Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes
  • Providing continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Medical Device Requirements
  • Ownership of highly visible, global, systemic CAPAs while partnering with a Community of Practice
  • Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process
  • Participates in appropriate BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning.
  • Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects



What We’re Looking For In You:

Minimum Qualifications

  • Bachelor's degree and 2+ years or Masters degree and 1 year or more of experience in a medical device manufacturing, quality or regulatory/compliance environment
  • Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization
  • Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
  • Must be willing to travel 25% of the time
  • Technical writing and documentation skills

Preferred Qualifications

  • Degree(s) in Science or Engineering
  • 2+ years of experience in Supplier Quality, Supplier Management, or Quality Systems
  • Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
  • Project management skills




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: 446570


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Quality, Healthcare