Software Quality Engineer Ii - Maple Grove, Mn

REQUIRED 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 an 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 the 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 a positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, and Labs, etc.).
• Hands-on approach, Self-motivated with a passion for solving problems.
  Requisition ID: 582280
  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 prohibited substance 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.
  Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
  Nearest Major Market: Minneapolis
  Job Segment: QA, Quality Assurance, Testing, Medical Device, Medical Device Engineer, Technology, Quality, Healthcare, Engineerin

ABOUT THE ROLE:

At Boston Scientific, the Software Quality Engineer II develops, establishes, and maintains Software Quality assurance methodologies, systems, and practices that 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 an FDA-Regulated Medical Device environment and ensuring that software verification and validation is conducted 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 perspective making sure changes are implemented in compliance with internal procedures and external standards.
• Review test results for GDP compliance and ensure 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 that 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 the completion of tasks. May participate in project teams.