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Senior Software Quality Engineer — Medical Device (Onsite — Maple Grove, MN) Possible Contract Extension

Pharmavise Corporation

  • Maple Grove, Minnesota
  • 30+ days ago

    Highlights

    May manage small to medium-sized projects by applying basic project management by applying basic project management methodology (e.g., project plan, schedule, budget, etc.). Serves as a Quality representative to improve awareness, visibility, communication on a quality initiatives to support departmental, functional, site, divisional and corporate software quality goals and priorities.

    Numbers & Facts

    LocationMaple Grove, Minnesota
    Websitehttp://www.pharmavise.com

    Description

    Job Summary:  

    Develops, establishes and maintains software quality engineering methodologies, programs, systems, and practices which meet Client, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on a quality initiatives to support departmental, functional, site, divisional and corporate software quality goals and priorities. Provides focused software quality engineering support within new product development, operational, or system/services support. Functional Engineering Roles include: Software Engineering, IT. 

     

    Key Responsibilities: 

    • Provides leadership role on championing departmental or cross-functional software development/programming/testing/validation/verification quality initiatives. 

    • Provides project direction, coaching, and mentoring for engineering and technical team personnel. 

    • Proactively investigates, identifies, and implements best-in-class Software Quality practices. 

    • Mentor for technical guidance for identifying and resolving software quality issues. 

    • Identifies and implements effective software quality systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. 

    • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external software quality requirements. 

    • Acts as an effective leader or team member in supporting software quality disciplines, decisions, and practices. 

    • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving software quality issues. 

    • Assures the development and execution of streamlined business systems which effectively identify and resolve software quality issues. 

    • May manage small to medium-sized projects by applying basic project management by applying basic project management methodology (e.g., project plan, schedule, budget, etc.). 

     

    Quality Systems Duties and Responsibilities: 

    • Build Quality into all aspects of their work by maintaining compliance to all quality requirements. 

      

    Qualifications: 

    • 9-11 Years of Experience if with a BS Engineering degree (Software Engineering degree preferred) 

    • 7-8 Years of Experience if with a MS degree 

    • Has experience leading large teams in Software testing 

    • Has an understanding of Software test review process 

    • Has experience in Software test architecture 

    • Has experience automation and manual test procedures for medical device environment 

    • Understands IEC-62304 standards in relation to Software verification and validation 

     

    Other Details: 

    • Schedule: 08:00 AM - 04:30 PM CDT 

    • Work Setup: Onsite in Maple Grove, MN 

    • No Travel Requirements 

    • Contract Length: 12 Months (September 8, 2025 – September 7, 2026) with Possible Contract Extension



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