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

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