Quality Software Engineer​/Computer Systems Validation Engineer

Quality Software Engineer / Computer Systems Validation Engineer

TEAM is seeking a Quality Software Engineer / Computer Systems Validation Engineer to join our team in Knoxville, TN. This position will be on-site at our Knoxville, Tennessee Corporate Office.

The Quality Software Engineer is responsible for ensuring that enterprise software systems—including Microsoft Dynamics 365 and the Electronic Quality Management System (eQMS)—are compliant, validated, and effective in supporting Team Technologies' operations. This role bridges quality engineering, software validation, and digital compliance, ensuring all platforms meet Federal Regulations and International Standards and guidance requirements using a risk-based approach.

ONE TEAM. MANY OPPORTUNITIES.

One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers. With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer’s business.

Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding principle: TEAM will grow by partnering with our customers to drive their growth. In the spirit of our founders’ guiding principles, we continue to grow by adding new technologies to broaden our capabilities and provide solutions for our customer partners. As ONE TEAM with MANY TECHNOLOGIES, we stand ready to be “YOUR PARTNER FOR WHAT’S NEXT”.

You can find TEAM in fourteen locations across the United States and three international locations.

• Ensure all software used in medical device processes complies with 21 CFR Part 11, 210/211, 820, ISO 13485, ISO 14971, and GAMP 5 principles.
• Develop and maintain validation documentation (URS, FRS, risk assessments, IQ/OQ/PQ, validation summary reports, traceability matrices).
• Support Computer Software Assurance (CSA) implementation for QMS, ERP (e.g., D365), and laboratory systems.
• Lead change control and re‑validation activities when software, configurations, or processes are updated.
• Access and validate AI tools.

• Collaborate with cross‑functional teams (Engineering, Manufacturing, Quality, IT) to evaluate and validate new software tools and applications.
• Assess risk impacts of software failures using FMEA, risk‑based testing, and defect tracking.
• Implement and monitor metrics/KPIs for software quality and system performance.
• Support audit readiness and provide documentation for FDA and ISO inspections.
• Identify opportunities to improve system usability, compliance efficiency, and data integrity.
• Provide training and guidance on software validation and compliance requirements to engineering and quality teams.
• Contribute to digital transformation projects by ensuring regulatory-compliant integration of new technologies.

• Computer literate, including statistical processing software such as Minitab.
• Ability to work as a team member with multiple departments, and build relationships with internal and external suppliers and customers.
• Ability to work independently with little oversight.
• Experience in software validation, quality systems, or regulated manufacturing (medical device, pharma, or biotech).
• Deep understanding of 21 CFR 820, Part 11, ISO 13485, ISO 14971, and GAMP 5 frameworks.
• Experience with Microsoft Dynamics 365, eQMS, or other validated quality/ERP systems.
• Strong technical writing and documentation skills; ability to generate clear, audit‑ready validation deliverables.
• Demonstrated ability to lead cross‑functional teams and manage multiple software validation projects simultaneously.
• Familiarity with Power BI, Smartsheet, or similar tools for reporting and tracking metrics is preferred.
• Bachelor’s degree in Engineering, Computer Science, Quality, or related technical discipline preferred.
• CQE, preferred.
• Minimum 3 years of experience in software validation, quality systems, or regulated manufacturing (medical device, pharma, or biotech).
• Experience in a GMP environment, highly preferred.
• Travel is required for meetings or training, up to 15%.