IQA Tech I: Onsite Quality Inspector (Medical Devices)

Techlink Systems Inc.; Irving (TX); On-site; USD 40,000 - 60,000; Full time

Job summary

Techlink Systems Inc. in Irving, TX seeks an IQA Technician I to support GMP/GLP compliant incoming inspections of materials and assemblies. You will perform visual and dimensional checks using calipers, gauges, and rulers, maintain records, and ensure compliance with FDA/ISO standards.

Interns welcome; prefer some inspection experience and ability to analyze data for trends. On-site role with standard daytime hours.

Qualifications

• Must perform accurate visual and dimensional inspections.
• Familiar with GMP, GLP, and quality system regulations.
• Strong documentation and record-keeping skills.
• Able to analyze inspection data and identify trends.
• High attention to detail and accuracy.
• Able to follow standards, procedures, and regulatory guidelines.
• Basic problem solving and initiative to complete tasks independently.

Responsibilities

• Support manufacturing and testing operations in compliance with GMP and GLP for receiving and inspection.
• Perform duties per Global and Technical Standards and QS requirements.
• Complete Tier 1 inspections per inspection plans and drawings to support production schedules.
• Use hand tools (calipers, gauges, rulers) and perform visual inspections on inbound materials for medical device assembly.
• Operate more advanced measuring instruments as needed.
• Perform visual and dimensional inspections of cable harness assemblies and PCBs.
• Maintain accurate inspection records, documentation, and filing systems to meet GMP and quality compliance.
• Accept or reject supplier lots based on inspection results.
• Document non-conformances related to specs, procedures, or standards, including paperwork and system transactions.
• Initiate discrepant material reports and participate in data collection, analysis, and trending.
• Recommend improvements to policies, processes, and procedures.
• Perform moderately complex assignments; escalate complex issues to senior quality personnel.
• Support QMS, EMS, and other regulatory initiatives.
• Ensure adherence to FDA, ISO, environmental, health, and safety requirements.

Skills

Visual inspections

Dimensional inspections

GMP/GLP knowledge

Documentation

Data trend analysis

Attention to detail

Regulatory compliance

Problem solving

Education

High School Diploma or GED

Bachelor's degree or technical diploma (preferred)

Tools

Calipers

Gauges

Rulers

Job description

Techlink Systems Inc. in Irving, TX seeks an IQA Technician I to support GMP/GLP compliant incoming inspections of materials and assemblies. You will perform visual and dimensional checks using calipers, gauges, and rulers, maintain records, and ensure compliance with FDA/ISO standards.

Interns welcome; prefer some inspection experience and ability to analyze data for trends. On-site role with standard daytime hours.