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Prin S/W QA Engineer

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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: 
This Principal Engineer will be responsible for the development, deployment and maintenance of Software Quality and Validation policies, procedures and methods in accordance with Boston Scientific and external regulatory requirements.  In this role you will provide expertise and guidance in interpreting regulations to ensure compliance; establish methods for monitoring the compliance of software system processes, standards and procedures; and proactively identify problems, drive to root cause and develop preventative problem-solving solutions independently.  

 

Your responsibilities include: 

  • Acts as lead project team member who provides independent review on validation deliverables used to develop, implement and maintain IT/clinical/manufacturing/Quality software.
  • Demonstrate mastery of the software validation processes at BSC (examples include GSM, Spreadsheet Validation). 
  • Plays leadership role in providing full guidance and direction on acceptability of deliverables in accordance with corporate policy requirements.
  • Apply sound judgment in permitting deviation from established processes to enable a superior outcome, while still complying with regulation requirements.
  • Responsible for the full definition and capability of a software system and for developing new methods and processes from strategy to execution while ensuring that Boston Scientific's software systems are defensible for regulatory requirements.
  • Proactively investigates, identifies and implements best-in-class Software Quality Engineering practices.
  • Proactively identifies industry best-practices and leads efforts to develop, improve, and simplify quality system practices. Contributes to the development, review and / or approval of SOPs and supporting Work Instructions.
  • Communicates the value of the Software Quality Assurance process to Boston Scientific and initiates buy-in to the process.  Establishes and supports global and classroom training curriculum and provides project direction, coaching and mentoring for the application teams.
  • Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results.
  • Partner with internal colleagues to influence or plan and execute strategies for continuous improvement in processes, standards and procedures that accommodate software quality, validation systems and/or compliance needs. 
  • Maintains and enhances cross-functional team relationships.  Works cross-functionally and across multiple sites in identifying and resolving technical issues.  Works with project managers to set priorities and plan resource and time allocation accordingly.
  • Develop structured Quality Assurance activities and metrics to promote efficient and cost-effective operations. 

 

What we're looking for: 

Required Qualifications

  • Bachelor’s level degree in Science/Engineering/Software discipline 
  • 9+ years of related experience, including 5+ years’ experience in Software Quality Assurance and validation.
  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11, SoX and cGxP for Medical Devices
  • Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements.
  • Experience in working with ‘Agile’ software development and validation methodologies.
  • Experience in supporting enterprise systems (examples include SAP) validation.
  • Must be able to apply project management principles and techniques as they relate to software project planning, implementation and tracking. Must be able to evaluate and manage risk.
  • Experience with work management and testing tools (such as JIRA, qTest)

Preferred Qualifications

  • Comfortable speaking and presenting to leadership
  • Strong written and verbal communication skills 
  • Creative and innovative thinking skills 
  • Experience working with a diverse population of internal and external customers
  • Comfortable working independently and as part of a cross-functional team 
  • Ability to manage multiple priorities and work without ambiguity

 

 

 

Requisition ID: 556984

 

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!


Nearest Major Market: Minneapolis

Job Segment: QA Engineer, Quality Assurance, QA, Compliance, Testing, Engineering, Quality, Technology, Legal

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