Job 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
- Contract Length: 12 Months (September 8, 2025 - September 7, 2026) with Possible Contract Extension
Job Tags
Full time, Contract work,