Quality Assurance Technician

About the role

VahatiCor is a venture-backed medical technology company developing a new cardiovascular therapy. As the company grows beyond its startup incubator, it is building the quality systems and infrastructure needed to support its next stage. The Quality Assurance Technician will inspect and test materials, components, subassemblies, and finished cardiovascular medical devices. As a member of the Quality team, this person will also carry out material control and nonconformance activities, maintain manufacturing and inspection records, and participate in validation activities. This is a hands-on role requiring medical device industry experience and the ability to work in compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality system requirements.

Responsibilities

• Perform incoming inspection and testing of medical device materials and components using approved specifications, inspection procedures, and sampling plans
• Collect and evaluate quality documentation accompanying incoming materials, including certificates of conformity, supplier inspection records, and other required documentation
• Perform in-process inspection and testing of subassemblies and final inspection of completed medical devices
• Inspect materials and products for applicable dimensional, visual, workmanship, labeling, and packaging requirements
• Use microscopes for detailed inspection of small components, assemblies, and finished devices, including extended periods of microscope use
• Use calipers, micrometers, height gauges, gauge blocks, optical inspection and measurement equipment, and other approved tools appropriate to assigned inspections
• Document and communicate inspection results, test results, and nonconformances according to approved quality system procedures and good documentation practices
• Work in cleanroom and electrostatic discharge-protected areas, as applicable, following required procedures for gowning, contamination control, and material handling
• Carry out material control procedures, including receipt verification, identification, quarantine, and movement of materials to and from Quality
• Verify material identification, part numbers, revision levels, lot or serial numbers, quantities, and inspection status against approved documentation
• Maintain material control, nonconformance, work order, and serial number logs and databases, as assigned
• Identify and document nonconforming materials or products and coordinate their segregation and status labeling to prevent unintended use
• Participate in the investigation, disposition, and documentation of nonconforming materials by gathering inspection results, measurements, manufacturing records, and other relevant information
• Perform approved reinspection or verification following authorized rework or other disposition decisions
• Escalate unresolved discrepancies and recurring defects to the appropriate Quality, Manufacturing, or Engineering personnel
• Contribute to and maintain lot records and Device History Records, including required inspection, manufacturing, and traceability information
• Review records for completeness, accuracy, legibility, required signatures and dates, and use of current approved document revisions
• Identify missing entries, inconsistent information, or incomplete approvals and coordinate correction with the responsible personnel
• Follow good documentation