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Quality Specialist II - eCAPA (Remote optional) Job

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Date: Sep 25, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional locations: This position may be based in any US Boston Scientific site or be remote. 


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.


Quality Specialist II - Remote 


About the role:
Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Collaborates with Quality management to recommend, design and implement functional process improvements.  Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.  Provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services.  May mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate.
Your responsibilities include:

  • Lead organizational change management of eCAPA software releases
  • Oversee completion of global CAPA process Value Improvement Process projects
  • Be a Lean Business Process champion and mentor for the Corporate CAPA team
  • Support CAPA compliance analysis and metrics
  • Lead and participate in the development and execution of streamlined and compliant CAPA systems and processes
  • Identify, prioritize, communicate, and resolve quality issues
  • Participate in or own NCEPs/CAPAs as appropriate
  • Develop and deliver communications and training as needed
  • Maintain global CAPA guidance website
  • Other duties as necessary or required by the department or organization

What we’re looking for in you:
Minimal qualifications:

  • Bachelor's degree and 2-4 years of work experience
  • Ability to read and interpret regulations
  • Strong understanding of CAPA requirements for medical devices
  • Excellent written and oral communication, technical writing and editing skills
  • Strong sense of responsibility and attention to detail
  • Ability to work with a global virtual team
  • Demonstrated initiative to identify and drive improvement opportunities
  • Strong project management skills and ability to lead and engage cross functional/ global teams
  • Ability to work in a fast paced, self-directed, environment
  • Advanced Microsoft Office suite skills
  • Data analysis skills and tools knowledge (Excel etc.)
  • Willingness to travel (<10%) 

Preferred qualifications:

  • Knowledge of the eCAPA system
  • SharePoint website editing skills
  • Continuous improvement and/or Lean/Six Sigma certification
  • 5+ years medical device work experience
  • Strong understanding of the BSC quality systems


Requisition ID: 501058


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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