OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a IQA Technician II in Irvine, CA. The IQA Technician II roleplays a critical role in ensuring that all incoming materials meet the strict quality standards required for the assembly of complex medical devices. This position supports manufacturing and testing operations in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory and company standards. The ideal candidate will have hands-on experience performing inspections, interpreting technical drawings, and operating a variety of measurement tools and advanced inspection systems. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• Perform Tier 1 and Tier 2 inspections of inbound materials to ensure conformance with specifications:
o Tier 1 Inspections: Routine manual inspections using tools such as calipers, rulers, ring/pin/thread/height gauges, and visual examination.
o Tier 2 Inspections: Advanced inspections using 2D/3D digital measuring projectors and optical testing instruments (e.g., OGP, Keyence IM).
• Inspect printed materials including labels, manuals, inserts, and digital media (CDs).
• Accept or reject supplier lots based on inspection outcomes, providing essential input for quality and supply chain decisions.
• Document non-conformances and suspected deviations in accordance with specifications, standard operating procedures, and regulatory standards.
• Analyze sampling and control plans to ensure compliance with engineering and QA requirements.
• Interpret technical drawings and perform comparative analysis between supplier and internal inspection methods.
• Suggest and implement alternative inspection methods when appropriate.
• Collect, analyze, and interpret inspection data to support problem-solving and continuous quality improvement.
• Set up, test, and troubleshoot inspection tools and systems specific to the QA area.
• Maintain compliance with FDA regulations, ISO 13485, GMP standards, and internal company procedures.
• Actively support QMS, EMS, and other regulatory initiatives.
• Follow all safety, environmental, and departmental SOPs and policies.
EXPERIENCE
2–5 years of experience in Quality Inspection in a regulated manufacturing environment, specifically medical devices.
EDUCATION
High School Diploma or GED required.
To be a best-fit your strengths must include:
• Strong experience with measurement equipment and tools (e.g., calipers, pressure/force gauges).
• Trained in blueprint reading and inspection sampling methodologies.
• Working knowledge of FDA regulations, GMP, ISO 13485.
• Proficient in Microsoft Word and Excel.
• Strong written and verbal communication skills.
• High attention to detail and critical thinking abilities.
• Ability to work independently and as part of a collaborative team.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.