QC​/QA Technician

IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary.

The Quality Control / Quality Assurance Technician supports the production of high-quality medical devices by performing inspections and testing of incoming materials, in-process assemblies, and finished products. This role ensures products meet defined specifications, regulatory requirements, and quality standards through hands‑on inspection, accurate documentation, and collaboration with cross‑functional teams.

The Technician plays a key role in maintaining compliance with Quality Management System Regulations (QMSR), supporting supplier quality activities, and enabling timely product release. Success in this position requires attention to detail, technical aptitude, and the ability to work effectively in a manufacturing and controlled‑environment setting.

• Perform incoming, in-process, and final inspection of materials, components and finished medical devices according to drawings, specifications and inspection plans.
• Conduct dimensional, visual, and basic functional testing using calibration inspection and test equipment.
• Review supplier documentation (Certificate of Conformance (CoC), Certificate of Analysis (CoA), test reports).
• Accurately record inspection and test results in Product Lifecycle Management (PLM) system.
• Perform data entry or movement of product in Enterprise Resource Planning (ERP) system.
• Support with quality data collection and basic rent reporting.
• Use and maintain inspection test equipment, verify calibration status and keep a clean and safe environment.
• Follow laser safety procedures and support inspection of laser‑based medical devices and optical components.
• Support sterile probe and finished product release activities by verifying inspection and documentation requirements are met.
• Perform final testing at supplier sites as required.
• Work with Manufacturing Engineers and Quality teams to support production and quality objectives.
• Cross‑train to support multiple inspection areas and perform other duties as assigned.

• High school diploma and/or relevant certification;
  Associate degree in Quality Assurance, Electronics, Optics, or related field preferred.
• 3‑5 years of related experience in a regulated manufacturing environment.
• Ability to communicate clearly and effectively, both verbally and in writing.
• Requires basic math and intermediate writing skills.
• Basic computer proficiency, including Outlook, Word, Excel, ERP, and PLM systems.
• Ability to read, follow and understand technical manuals, schematics, prints, specifications and instructions.
• Experience using basic measurement/inspections tools (calipers, micrometers, pin gauges, microscopes).
• Strong attention to detail and documentation accuracy.
• Comfortable working on the manufacturing floor and interacting with suppliers.
• Willingness to travel occasionally for supplier inspections and testing.
• Ability to lift and carry materials up to 20‑25 lbs. frequently and stand or sit for extended periods.
• Manual dexterity to handle small parts and inspection equipment.
• Understanding of the Quality System Regulation preferred.
• Ability to work in a controlled environment room with no medical restrictions.

• Department: Quality Affairs
• Reports To: QA/QC Manager
• FLSA Status: Non‑Exempt
• Hourly rate: $27 - $32 (DoE)
• Work Location: 100% onsite in Mountain View, CA