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Software Quality Engineer II Job

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Date: May 31, 2019

Location: *** MINNESOTA ***, MN, US, *** do not

Company: Boston Scientific



Location: US-MN-Maple Grove



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.




About This Role:

Develops, establishes and maintains software quality assurance methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused software quality assurance support within new product development, operational, or system/services support.



Your Responsibilities Will Include:

  • Working within a team of Software Quality Assurance Engineers that support manufacturing, Laboratory, R&D and IT systems.
  • Actively contributing to all aspects of Software Quality Assurance activities in a FDA-Regulated Medical Device environment and ensure that software verification and validation is carried out in compliance with site/corporate policies and procedures.
  • Perform independent review of design, development, and testing of software/firmware used in Boston Scientific Interventional Cardiology and Peripheral Interventional product lines during their entire System Development Life Cycle, from the Requirements gathering phase to the Retirement phase.
  • Review and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, Functional and design specifications, Design reviews, Test Protocols, Requirements trace matrix and Qualification Report along with support documentation for equipment and systems.
  • Review and approve changes to existing systems from a Software QA prospective making sure changes are implemented in compliance with internal procedures and external standards.
  • Review test results for GDP compliance and ensures that all test discrepancies to acceptance criteria are adequately controlled, documented and addressed.
  • Ensures that best software QA practices are employed by all departments so that software/Firmware based systems are developed, qualified and maintained in a manner which provides assurance that the system conforms to both internal and external requirements.
  • As required, support site audits, non-Conforming Events and CAPA’s.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • Establish and cultivate internal business relationships to facilitate completion of tasks. May participate in project teams



What We’re Looking for In You:

Minimum Qualifications

  • Bachelor’s level degree or higher in Science/Engineering/Software discipline.
  • 3+ years of related work experience in Software QA and/or computer systems validation.
  • Experience working in FDA-regulated industry.
  • Knowledge of System development life cycle (SDLC) preferably with automated manufacturing and computerized lab systems.

Preferred Qualifications

  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature).
  • Experience in supporting manufacturing of medical devices is desired.
  • Must possess excellent organizational, clear verbal and written communication skills.
  • High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once.
  • Must be team-oriented with people skills and positive can-do attitude in dealing with a large number of customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, and Labs, etc).
  • Hands-on approach, Self-motivated with a passion for solving problems




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: 447175


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