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Sr Quality System Engineer Job

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Date: Jun 3, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


Senior Engineer, Quality Systems 


About this role:
This is a senior role within the Marlborough Quality Systems group to maintain and improve the performance of the Quality function within the Marlborough site and across the Endoscopy and Urology & Pelvic Health divisions.

Provides cross-divisional Quality Systems support through the coordination of various elements within the Quality System Management and CAPA processes within the BSC Global Quality System. Provides technical guidance and leadership to Quality Systems and other personnel on compliance with BSC and external requirements. Liaise with cross functional SMEs to gather data in support of corporate and site goals and objectives. Drives a culture of continuous improvement and collaboration within the Quality Systems group.


Your responsibilities include: 

  • Coordination and preparation of Quality Management Review meetings for the Endoscopy and Urology & Pelvic Health divisions.
  • Act as a Lead or Support Auditor for audits as necessary within the Marlborough Internal Audit Schedule.
  • PIR Coordination for the Marlborough site.
  • QN Coordination for the Marlborough site.
  • Support external audits as required in either a backroom or front room role as required.
  • Report on KPI and metric information as required to support divisional or site needs
  • Support the site corrective and preventive actions process as a CAPA Coordinator or Mentor as required.
  • Support the Complaints Review Board process as required.
  • Act as an expert resource in external regulations and standard requirement knowledge for cross functional teams
  • Ongoing maintenance and updates to Marlborough site level procedures.
  • Champions continuous improvement and innovation from a quality perspective within the department.
  • Supervision and management of other personnel, as required.
  • Representation of Marlborough site on various Communities of Practice and active engagement in those communities.


What we’re looking for in you:

Minimum Qualifications

  • 5-8 years’ experience in Quality with a Bachelor’s degree Engineering or related technical discipline.
  • Excellent written and verbal communication skills.
  • Working knowledge and understanding of QSR, ISO and EU MDR and other medical device industry quality requirements.
  • Proven ability to work well as part of a team or alone with minimum supervision.
  • Demonstrated ability to identify and work with cross functional organizations to solve problems.
  • Strong command of MS Office – Word, Excel, Powerpoint, Visio
  • Ability to rapidly learn and use new applications


Preferred Qualifications

  • Previous experience in Quality Assurance, Quality Engineering or Quality Systems background.
  • Experience in the medical device industry
  • Working knowledge of regulations and standards related to medical devices.
  • Previous experience with BSC systems (Windchill, eCAPA, SAP, etc)


Requisition ID: 480229


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Nearest Major Market: Boston

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