Senior Quality Technician

A growing medical device company is hiring a Senior Quality Technician to support Design Verification Testing (DVT) and engineering characterization for its next-generation Continuous Glucose Monitoring (CGM) devices. You’ll work hands-on in the lab with R&D and Quality teams. The work covers test protocols, inspection, root cause investigations, and writing up results within the Quality Management System (QMS).

• Run verification and validation (V&V) testing on electrical components, PCBA subassemblies, and sensors.
• Use lab and test equipment (gages, Keyence vision system, multimeters, oscilloscopes, power supplies) to check electrical and mechanical performance.
• Support durability, shipping (ASTM), and accelerated/reliability testing, both in-house and with third-party labs.
• Take apart and inspect test units and returned devices to find the root cause of failures.
• Analyze data with Minitab and Excel, spot trends, and support corrective and preventive actions (CAPA).
• Write test reports and failure investigation reports that follow Good Documentation Practices (GDP), ISO 13485, and FDA QMSR.
• Work with Engineering, Manufacturing, and Operations to resolve quality issues.

• 3–5 years of medical device experience, including at least 3 years in Quality Engineering or Quality Systems.
• Hands-on lab testing experience: inspection, failure investigations, and mechanical, durability, and reliability testing.
• Experience working within ISO 13485 and a QMS, with accurate data recording.
• Skill with statistical analysis (Minitab) and Microsoft Office.
• Associate’s degree in a technical or engineering field, or equivalent experience.

• Experience with destructive analysis, such as cross-sectioning.
• Familiarity with ISO 9001, ISO 14971, IEC 60601, and ASTM standards.