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Sr Quality System Engineer Job

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Date: Jul 19, 2019

Location: Cambridge, MA, US, 02138

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.


Sr. Quality Systems Engineer

About the role:

Supports and maintains quality system methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serve as Lead Quality System representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. 

Your Responsibilities Include:

  • As Cambridge Quality Systems Lead, support and  maintain the Quality System in Cambridge which is composed of Management Controls, Internal Audit, Document and Record Controls, Design Controls, Post Market Support and CAPA.
  • Collaborate with members of the Quality Systems Teams at our partner sites in Arden Hills MN, Heredia, Cost Rica and Marlboro MA. 
  • Work to become an expert in the Boston Scientific Global CAPA System.  Own non-conformance reports (NCEP), corrective actions (CAPA) and document and records control activities as needed.  Mentor personnel involved in those activities. 
  • Own important Quality System responsibilities like Quality Management Review, CAPA review, Complaint Review, Internal and External Audits, Non-Conforming Events, Non-Conforming Materials, Non-Conforming Products, CAPA, PIR and Field Actions. Mentor personnel involved in those activities. 
  • Establish and meet the Internal Audit schedule.  Collaborate with other BSC sites to provide personnel to conduct Internal Audits in Cambridge as needed.  Participate as auditorfor  Internal Audits at sister sites.
  • Interact and partner with Cambridge Site and Division Management, subject matter experts, corporate stewards and other personnel who support the Boston Scientific Global Quality Systems.
  • Own Quality System Reports, Records and slide decks used to support official presentations to the Cambridge Site Management, Division Management and Corporate Quality.
  • Complete trend analysis and capture metrics for reports including non-conformance records, corrective action  records, training records and audit records.
  • Act as team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.


What we’re looking for in you:

Minimum Qualifications

  • 5+ years of Medical Device experience
  • BS in Engineering or related technical discipline
  • Ability to work in a fast paced, dynamic environment
  • Team player
  • High energy problem solver capable of driving items to closure



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: 447841


Nearest Major Market: Cambridge
Nearest Secondary Market: Boston

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