Quality Assurance Supervisor

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GT Medical Technologies, Inc. provided pay range:
This range is provided by GT Medical Technologies, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$78,000.00/yr – $/yr

Annual Bonus

The journey of a brain tumor patient is profoundly emotional. Many newly diagnosed patients first arrive in the emergency department after experiencing sudden changes in vision, balance, or cognitive function. Their lives are turned upside down as they quickly prepare for surgery. Sadly, for about half of glioblastoma patients, the tumor returns within months—forcing patients, their families, and their care teams to face another round of difficult decisions.

It’s been more than a decade since patients have had a truly innovative treatment option—until Gamma Tile® Therapy. At GT Medical Technologies, our purpose is clear:
Improve the Lives of Patients with Brain Tumors. Guided by our shared values of Empathy, Empowerment, and Excellence, we are dedicated to providing better options for patients, caregivers, and clinicians alike.

More than 120 passionate teammates make up GT Medical Technologies. We collaborate naturally, challenge one another constructively, and share an unwavering commitment to helping the next patient. With an exceptional core team, an innovative therapy, and the resources to support our mission, GT Medical Technologies is well‑positioned to deliver the best possible therapy for patients.

The Quality Assurance (QA) Supervisor is responsible for overseeing the quality control operations within the medical device manufacturing environment to ensure compliance with all applicable regulatory requirements, including FDA regulations (21 CFR Part 820), ISO 13485, and internal quality standards. This role provides leadership and direction to the QA Technician group, ensuring that products meet established quality specifications and company objectives for safety, efficacy, and performance.

The QA Supervisor will coordinate day‑to‑day activities related to product and raw material inspection, device history record reviews, release of product for distribution, environmental monitoring of the cleanroom environments, and product testing. The QA Supervisor will assist in the nonconformance process and serve as QA representative for the Material Review Board.

• Supervise and coordinate all incoming, in‑process, and final inspection/testing activities for medical device components and finished goods.
• Ensure compliance with quality assurance procedures, specifications, and regulatory standards.
• Coordinate and assist with process audits to ensure compliance with procedures and regulations.
• Review and approve inspection records, test data, batch records, and device history records (DHRs) prior to product release.
• Train, evaluate, and mentor the QA Technician group, ensuring proficiency in inspection techniques, documentation review, and regulatory compliance.
• Support investigations of nonconformances and product quality issues, contributing to root cause analysis and corrective actions.
• Coordinate equipment calibrations and review and approval of calibration and maintenance records.
• Coordinate environmental monitoring of the clean rooms.
• Collaborate with cross‑functional teams to support process validations and quality improvements.
• Prepare QA metrics and reports to monitor department performance and support management review.
• Other duties as assigned.

• Bachelor’s degree in a scientific, technical, or engineering discipline, or equivalent experience preferred.
• Minimum of 3–5 years of experience in Quality Control within the medical device or regulated life sciences industry.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
• Prior experience supervising or leading inspection or testing teams is preferred.
• Familiarity with measurement tools, inspection methods, and quality data analysis.
• Excellent attention to detail, organizational skills, and…