Pharmavise Corporation · 4 months ago
Senior Software Quality Engineer — Medical Device (Onsite — Maple Grove, MN) Possible Contract Extension
Pharmavise Corporation is a company in the Medical Device industry, seeking a Senior Software Quality Engineer to develop and maintain software quality engineering methodologies that meet client and regulatory requirements. The role involves providing leadership in software quality initiatives and mentoring technical team personnel while ensuring compliance with quality standards in product development and manufacturing.
Food and BeverageHealth Care
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.)
Build Quality into all aspects of their work by maintaining compliance to all quality requirements
Qualification
Required
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