Senior Software Quality Engineer — Medical Device; Onsite — Maple Grove, MN

Overview

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

• 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, and communication on 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.
• 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.
• Mentors for technical guidance for identifying and resolving software quality issues.
• Identifies and implements effective software quality systems to support the development, qualification, and ongoing 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 methodology (e.g., project plan, schedule, budget).
• Build Quality into all aspects of work by maintaining compliance to quality requirements.

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

• 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

• 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

• Mid-Senior level

• Contract

• Information Technology

• Medical Equipment Manufacturing