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
  M
  S
  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
  T
  ravel
  R
  equirements

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