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Sr Quality System Engineer Job

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Date: Jun 20, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

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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.


Senior Quality Systems Engineer


About the role:

The Senior Quality System Engineer will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives and objectives through the support of assigned departmental and corporate quality goals and priorities.  Specifically, the Senior Quality System Engineer will drive projects to improve the compliance, efficiency, and agility of the global CAPA processes and systems (i.e. Nonconforming Events, CAPA, Field Action assessment, etc.).  They will also serve as a mentor for Corporate CAPAs and will provide guidance to local sites as needed.


This role is located in Marlborugh MA, but could be open on any BSC global site for internal candidates.


Your responsibilities include:

  • Proactively investigates, identifies, and implements best-in-class quality practices.  Advise management on potential enhancements to quality systems and processes.
  • Collaborates with members of the CAPA communitiy from all sites to deliver process improvements for the global CAPA processes.
  • Partner or lead cross functional teams to deliver departmental or Corporate projects.
  • Stewards one or more CAPA communities of practice with global site representation to drive projects which increase compliance, efficiency, and agility for improved outcomes.
  • Act as a subject matter expert in the Boston Scientific global CAPA System for both internal and external customers (e.g. auditors, cross fucntional team member, regulatory agencies, etc).
  • Drive the continued harmonization and standardization of CAPA procedures across the BSC plant network.
  • Provides mentorship to CAPA owners to ensure compliant and timely records through sound problem-solving practices and scientific methods.
  • Complete trend analyses and capture metrics for reports including CAPA review board, management review, nonconformance records, and CAPA records.
  • Continuously adds to their working knowledge and application of business and technical concepts, procedures and practices through internal and external training and seminars.
  • Develops solutions to problems of varying complexity and leads projects of significant scope involving global processes and enterprise-wide electronic systems.
  • Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established procedures, etc. as needed


What we’re looking for in you:

  • Bachelors of Science or Engineering with 2-5  years of relevant experience in medical device quality or manufacturing
  • Proficient in MS Office applications (Word, Excel, Powerpoint, Visio, etc.)


Preferred Qualifications:

  • ASQ Certification (CQE preferred)
  • AAMI Certification (Quality System Regulations preferred)
  • Software validation experience in a regulated industry




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: 445274


Nearest Major Market: Boston

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