myGwork - LGBTQ+ Business Community · 2 days ago

Software Quality Engineer II

Maple Grove, MI

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

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.

Qualification

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Software QAComputer Systems ValidationFDA RegulationsSDLCAutomated ManufacturingComputerized Lab Systems21 CFR Part 11Manufacturing of medical devicesComplianceSupport multiple deliverablesHands-on approachProblem-solvingHard-workingOrganizationalCommunicationAttention to detailTeam-orientedPeople skillsPositive attitude

Required

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

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.