Job Title: Incoming Quality Assurance (IQA) Technician I
Location: Irving, TX 75038
Position Type: 6-Month Contract
Job Summary
We are seeking an IQA Technician to support receiving and inspection operations in a regulated manufacturing environment. This role is responsible for conducting visual and dimensional inspections on inbound components, maintaining detailed quality records, and ensuring strict compliance with Good Manufacturing Practices (GMP) and Quality Management System (QMS) standards.
Duties & Key Responsibilities
- Support manufacturing and testing operations in compliance with GMP and Good Laboratory Practices (GLP) for receiving and inspection.
- Perform job duties in accordance with global technical standards and Quality System requirements.
- Complete Tier 1 inspections according to inspection plans and engineering drawings to support production schedules.
- Utilize hand tools (calipers, gauges, rulers) to conduct visual and dimensional inspections on inbound materials for device assembly.
- Inspect cable harness assemblies and printed circuit board assemblies (PCBAs) for visual and dimensional accuracy.
- Maintain accurate inspection records, technical documentation, and filing systems to meet regulatory and quality compliance.
- Make accept/reject decisions on supplier lots based on inspection findings and established criteria.
- Document non-conformances related to specifications, procedures, or standards, completing all required paperwork and system transactions.
- Initiate discrepant material reports (DMRs) and assist with data collection, analysis, and trending.
- Identify and recommend continuous improvement opportunities for policies, processes, and procedures.
- Perform moderately complex assignments applying established methods; escalate complex quality issues to senior personnel.
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory initiatives.
- Ensure strict adherence to FDA, ISO, environmental, health, and safety regulations.
Key Skills & Competencies
- High attention to detail and accuracy in performing visual and dimensional inspections.
- Strong familiarity with GMP, GLP, ISO, and standard quality regulations.
- Excellent technical documentation and record-keeping capabilities.
- Ability to review inspection data and assist in trend analysis.
- Basic problem-solving skills with the self-motivation to execute tasks independently.
- Ability to consistently follow controlled procedures, engineering drawings, and regulatory guidelines.
Requirements & Qualifications
Required:
- High School Diploma or GED.
- 0-2 years of experience performing incoming dimensional inspections.
- Hands-on experience using measurement tools (calipers, gauges, rulers, micrometers).
- Demonstrated ability to read and interpret engineering drawings, specifications, and inspection plans.
Preferred:
- Bachelor's degree or technical diploma (preferred if candidate lacks direct inspection experience; entry-level/intern candidates will be considered).
- Previous experience supporting a quality or manufacturing environment, ideally within medical devices or a regulated industry.