Med Device Software Quality Leader — Onsite

Pharmavise Corporation; Maple Grove (MN); On-site; USD 110,000 - 165,000; Full time

Job summary

Pharmavise Corporation is seeking a Senior Software Quality Engineer to join our onsite Maple Grove, MN team. You will lead software quality initiatives across development, testing, validation, and regulatory alignment for medical device projects.

You will mentor engineers, drive CAPA and quality systems, and ensure IEC 62304 compliance while collaborating with cross-functional groups to meet internal and client 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

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.

Skills

Software testing leadership

Test automation

Manual testing

IEC 62304 knowledge

Software verification and validation

Education

BS in Engineering (Software Eng preferred)

MS degree

Job description

Pharmavise Corporation is seeking a Senior Software Quality Engineer to join our onsite Maple Grove, MN team. You will lead software quality initiatives across development, testing, validation, and regulatory alignment for medical device projects.

You will mentor engineers, drive CAPA and quality systems, and ensure IEC 62304 compliance while collaborating with cross-functional groups to meet internal and client requirements.