: ONSITE IN MAPLE, GROVE, MN. FIRM.

Business Title: SW Quality Engr, Sr.

Job Purpose Develops, establishes and maintains software quality engineering methodologies, programs, systems, and practices which meet BSC, 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.

**Person will be working with a Lead and team of approximately 9-10.

Key Responsibilities 1. Provides leadership role on championing departmental or cross-functional software development/programming/testing/validation/verification quality initiatives. 2. Provides project direction, coaching, and mentoring for engineering and technical team personnel. 3. Proactively investigates, identifies, and implements best-in-class Software Quality practices. 4. Mentor for technical guidance for identifying and resolving software quality issues. 5. 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. 6. Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external software quality requirements. 7. Acts as an effective leader or team member in supporting software quality disciplines, decisions, and practices. 8. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving software quality issues. 9. Assures the development and execution of streamlined business systems which effectively identify and resolve software quality issues. 10. 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 with BS Engineering degree (Software Engineering degree preferred); MS degree, with 7-8 yrs experience 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