Quality Assurance Technician

Quality Technician I

Hiring a Quality Technician I to support the Design Quality Engineering Team for a Medical Device Company in Santa Clara, CA!

• Observe a wide range of tests, including DV tests, lot release tests, and data acquisition activities, to ensure they follow established methods and protocols.
• Monitor the application of Good Documentation Practices (GDP) during testing and inspection activities and record any GDP issues identified.
• Occasionally perform tests directly while primarily focusing on monitoring, understanding, and verifying test methods and procedures.
• Read, understand, and interpret test methods and protocols, including those related to device use, dimensional measurements, and other product-specific requirements.
• Communicate test and inspection observations clearly to engineers and act as the primary point of visibility on the testing floor.
• Perform incoming inspections when required and participate in explaining noncompliance issues to engineers and supporting resolution on the line.
• Prepare test lines before testing by ensuring equipment is calibrated, preventive maintenance is completed, and all items are appropriately labeled.
• Review test and inspection data to ensure compliance with Good Documentation Practices (GDP).
• Audit data collection processes to confirm adherence to GDP and identify opportunities for improvement.
• Review test data for accuracy when transferring or transcribing information from data collection forms into statistical or calculation software files for analysis.
• Review inspection and testing reports for compliance with Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files according to established procedures.
• Perform inspection and functional testing of medical device components, tools and fixtures, subassemblies, and finished goods using various measurement systems such as Scienscope, laser micrometers, pin gauges, height gauges, optical instrumentation, Instron, calipers, snap/drop gauges, and balloon burst testers.
• Generate Non-Conformance Reports (NCRs) when inspection or testing results do not meet specifications or test protocol requirements.
• Conduct functional testing of components, assemblies, and finished products in accordance with required specifications or test protocols.

• High school diploma or equivalent.
• Minimum of 1 year of experience in the medical device industry, preferably in Quality Assurance.
• Hands-on experience with inspection and functional testing of medical device components, assemblies, and finished goods.
• Ability to understand and follow Quality Management System procedures.
• Knowledge of Current Good Manufacturing Practices (cGMP) and Good Manufacturing Practices (GMP).
• Understanding of Quality System Regulations (QSR) and FDA regulatory expectations for medical devices.
• Strong familiarity with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
• Ability to read, interpret, and follow test methods, protocols, and specifications accurately.
• Competence in reviewing and validating test and inspection data for accuracy and completeness.

Job Type &

Location:

This is a Contract to Hire position based out of Santa Clara, CA.

Pay and Benefits:

The pay range for this position is $20.00 - $25.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision;
Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available;
Life Insurance (Voluntary Life & AD&D for the employee and dependents);
Short and long-term disability;
Health Spending Account (HSA);
Transportation benefits;
Employee Assistance Program;
Time Off/Leave (PTO, Vacation or Sick Leave).

Workplace Type:
This is a fully onsite position in Santa Clara, CA.

Final date to receive applications:
This position is anticipated to close on Aug 26, 2026.