Quality Assurance Inspector I

🌟 Join Argen as a Quality Assurance Inspector I🌟 **Location:** 8515 Miralani Dr, San Diego, CA 92126 **Schedule:** Monday–Friday, 8:00am – 4:30pm Argen, a global leader in digital dentistry and dental materials, is seeking an HR Generalist to support benefits & LOA administration, HRIS reporting, recruiting, onboarding, and compliance. If you thrive on details, communication, and project management, this role is for you. 🧩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 ISO 13485:2016, 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, ISO 13485, 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