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Sr Quality Systems Engineer Job

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Date: Aug 12, 2019

Location: Santa Rosa, CA, US, 95403

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 Senior Quality Systems Engineer 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 execution of the Quality System at the Santa Rosa facility, ensuring compliance to Medical Device regulations and BSC Quality System requirements.



Your Responsibilities Will Include:

  • Responsible for the execution of elements of the Quality System such as Management Review, External Audit Readiness, Readiness Review and Other Quality Assurance projects.
  • Lead the internal audit program including schedule creation, audit execution, training
  • Responsibilities within the CAPA process including Mentor/Coordinator roles, lead CAPA review Board, ensure adherence to NCEP/CAPA metrics across the site
  • Lead and manage projects associated with site quality initiatives to assure that the site’s interests are accurately and objectively represented from a quality perspective. 
  • Lead functional teams in developing solutions for quality related issues and seeking new opportunities for continuous improvement.
  • Serve as Quality Assurance representation on project teams by providing guidance for maintaining compliance to regulatory and corporate requirements.       
  • Provide technical support and leadership within the Quality Assurance and Quality Systems organization to support the Quality Policy and Quality System.
  • Act as a technical resource within the facility for review, approval and resolution of non-conformities within the facility



What We’re Looking For In You:

Minimum Qualifications

  • BS in an engineering discipline with 5+ years of technical experience or Master’s degree and 3+ years of experience
  • Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
  • Experience in nonconforming material and CAPA methodologies/systems preferred.
  • Strong communication, presentation, facilitation, and project management skills.
  • Proficiency with Microsoft Office suite.
  • Applies continuous improvement principles in the development of the quality system.
  • Driven, energetic, self-assured professional with high personal integrity.
  • Ability to develop effective, positive interpersonal relationships.              



Preferred Qualifications

  • Lead auditor Certified (ISO 13485), ASQ CQE/CQA
  • Experience in Medical Device Industry
  • Proven 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: 450608


Nearest Major Market: Santa Rosa
Nearest Secondary Market: Petaluma

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