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Quality Systems Engineer I Job

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Date: Apr 8, 2021

Location: Quincy, MA, US, 02171

Company: Boston Scientific

Additional Locations:

 

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.

About the role:
The Quality System Engineer will utilize quality engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall Boston Scientific business and quality vision while complying with company and regulatory policies.

 

Your responsibilities will include:

  • Provide technical support and leadership within the Quality Systems and overall 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, CAPA Review Board, Audit Readiness and Other Quality related projects.
  • Revise Quality System standard operating procedures, as applicable.
  •  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 NABP compliant and maintain on going related certifications.
  • Support projects associated with site quality initiatives to assure that the distribution center’s interests are accurately and objectively represented from a quality perspective. 
  • Support functional teams in developing solutions for quality related issues and seeking new opportunities for continuous improvement.
  • Serve as Quality System representation on project teams by providing guidance for maintaining compliance to regulatory and corporate requirements.
  • Support continuous improvement projects, CAPA and LEAN initiatives at Quincy site and on Boston Scientific Global projects.

 

What we’re looking for in you:

Basic Qualifications:

  • BS in an engineering discipline (or similar related education and experience)
  • Strong communication, presentation, facilitation, and project management skills.
  • Proficiency with Microsoft Office suite.
  • Ability to develop effective, positive interpersonal relationships. 
  • Ability to work independently and on a team.             

 

Preferred Qualifications:

  • 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, and/or experience with supporting internal/external audit programs.
  • Driven, energetic, self-assured professional with high personal integrity.

Requisition ID: 478068

 

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

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