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Quality System Manager II Job

Additional Locations: 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.


Quality System Manager II


About the role:

Lead the oversight and integrity of Quality for Boston Scientific devices for assigned site or portion of a site. Support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines. May support Corporate and/or Ops from a Quality Systems perspective. Champion all compliance activities within assigned area. Create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. Ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.


Your responsibilities include:


Corporate Steward for Management Controls and Quality Planning:

  • Lead Communities of Practice for Management Controls and Quality Planning
  • Lead corporate wide strategic initiatives.
  • Drive BEST4 outcomes.
  • Identify and achieve annual VIP targets.
  • Ensure BSC Global Quality system incorporates relevant regulations and standards.
  • Participate on relevant standards working groups and initiatives (i.e. ISO 13485).
  • Facilitate Global Management Review process, including Executive Committee Management Review.
  • Manage all Global and Corporate procedures and documents within Management Controls and Quality Planning.


External Audit Support for BSC Network:

  • Ensure Audit Readiness at Corporate site and across network.
  • Lead quarterly Signals Review meetings .
  • Identify and communicate inspection and enforcement trends by FDA, Notified Bodies and Competent Authorities.
  • Manage Corporate Audit Support function.
  • Facilitate writing, review and delivery of all FDA 483 observation responses and Competent Authority non-conformity responses.
  • Facilitate corporate review of Notified Body non-conformity responses.
  • Lead BSC EU MDR QS Project Workstream
  • BSC EU GDPR QS Privacy Champion


Management of Notified Bodies for Quality System Certifications and Audits:

  • Ensure positive relationships are established and maintained between BSC and the respective Notified Bodies.
  • Establish and maintain service agreements with Notified Bodies.
  • Manage Global/Corporate quality system processes and procedures supporting Notified Body Quality System certifications.
  • Manage annual blanket Purchase Orders - approve invoices and monitor spend to budget.
  • Drive cost reductions and service improvements.
  • Minimize Notified Body audit impact on BSC network.
  • Lead BSC EU MDR QS Workstream and implementation strategy to obtain certification of the Global QS to EU MDR in 2019.
  • Partner with Divisional and Corporate Regulatory Affairs on certification and audit strategies.
  • Establish Notified Body audit schedules – Recertification, surveillance, expansion of scope.
  • Work with Quality and Regulatory acquisition teams to ensure notified body certification strategy is in alignment with corporate notified body strategy.


What we’re looking for in you:

Basic Qualifications: 

  • Bachelor’s degree and at least 7 years’ experience in quality/operations
  • 3 years of management experience in Operations/Quality function within the medical device industry
  • Excellent interpersonal skills
  • Strong presentation skills and MS Office skills
  • Experience with major systems (e.g. eCAPA, PDM, SAP,  VIP) desirable
  • Strong analytical 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: 439196


Boston Scientific
Full time
Marlborough, MA 01752, US