Quality Assurance Inspector I

Location 8515 Miralani Dr, San Diego, CA 92126 Schedule Monday–Friday, 5:00am – 1:30pm About the Role The Quality Assurance Inspector I plays a pivotal role in ensuring the quality and integrity of Argen products. This position is responsible for inspecting in-process and finished goods within manufacturing areas to ensure compliance with ISO13485:2016, FDA regulations, customer specifications, Argen requirements, and applicable procedures. Key Responsibilities Conduct in-process and final inspections and testing as required. Perform visual inspections of finished products. Participate in internal assessments and audits. Maintain accurate inspection and test records. Identify and properly label non-conforming materials. Communicate product/material acceptability to production personnel. Assist with technical problem-solving and special projects. Maintain lot traceability, log sheets, and housekeeping standards. Follow safety policies and regulations to ensure safe work practices. Ensure lab cleanliness and safety standards are upheld. Perform thorough inspections during and after production to ensure quality and compliance. Verify product labeling for accuracy and regulatory compliance. Clear and prepare production lines for subsequent runs. Review and validate Device History Records (DHRs) for completeness and compliance. Perform other duties as assigned. What You Bring High school diploma or equivalent required. Experience in a GMP-regulated facility is a plus. Completion of 8 hours of Quality Training (PTC) required. Strong attention to detail. Proficiency in basic arithmetic and problem-solving. Understanding of raw materials, production processes, and quality control. Familiarity with administrative procedures and computer systems. Effective written and verbal communication skills. Ability to interpret technical drawings, artwork, and procedures. Commitment to safety and quality standards. Ability to follow site protocols, policies, and procedures. Flexible, motivated, and capable of working independently. Strong organizational and time-management skills. Problem-solving abilities. Ability to learn technical concepts through documentation and training. Preferred knowledge of regulatory standards including: cGMP, ISO13485, 21 CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16/2013, MHLW MO 169, TG(MD)R Sch3 Why You’ll Love Working at Argen Competitive pay and full benefits package Medical, dental, and vision insurance 401(k) with employer match Paid time off and wellness programs Employee events and exclusive discounts A collaborative, innovative, growth-focused culture #J-18808-Ljbffr