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Quality Systems Engineer II Job

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Date: Aug 14, 2019

Location: Quincy, MA, US, 02171

Company: Boston Scientific

Additional Locations: (n/a)



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 Systems Engineer II


About the role:

The Quality Systems Engineer II will utilize quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  They will serve as a Quality representative to improve awareness, visibility, and communication on quality assurance initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. 


Your responsibilities will include:

  • 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.
  • Site champion for elements of the Quality System such as Management Review, Audit Readiness, Readiness Review and Other Quality Assurance projects.
  • Review and approve CRs, PCAF, DCAF, for changes to existing and new processes from a quality perspective.
  • Revise standard operating procedures, performs investigation of Drug material through review of customer processing records and licenses data base in SAP.
  • Responsible for supporting the site Drug Pedigree program, maintain State Level Licensing for all states that require license to distribution prescription medical device or Prescription Drugs.
  • Ensure site is Verified Accredited wholesale distributor (VAWD) compliance and maintain on going relation with VAWD and have site ready bi-annually for VAWD audit.
  • Lead and manage projects associated with site quality initiatives to assure that the distribution center’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.       
  • Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.
  • Implement use of quality assurance tools both internally and externally with the goal of improving control or addressing gaps to manufacturing and distribution processes and to eliminate non-value added activities.
  • Root cause analysis, and cause and effect analysis.
  • Performs other duties as required, including VIP.


What we’re looking for in you:

Basic Qualifications

  • BS in an engineering discipline with 2-4 years of technical 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

  • Medical Device or Pharmaceutical experience
  • ASQ CQE certification
  • Certified Green or Black Belt


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: 449774


Nearest Major Market: Boston

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