Quality Assurance Inspector I

Quality Assurance Inspector I Monday - Friday, 9:30pm - 6:00am About Us At Argen, we're in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We have a team of 400 Awesome team members. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that span fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen's products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed. About the Opportunity The Quality Assurance Inspector I plays a pivotal role in ensuring the quality and integrity of Argen products. Inspects works in-process and finished goods in manufacturing areas to ensure conformance as defined by ISO 13485:2016, FDA regulated standards, customer specifications, Argen requirements, and applicable procedures. In this role, the successful candidate will: Provides in-process/final inspection and testing as required. Performs visual inspections of finished products. Participates in internal assessments and audits as required. Maintains proper inspection and test records. Assures that non-conforming material has been properly identified. Advises the responsible production personnel of the acceptability of products or materials based on results of testing and/or inspection. Provides solutions to technical problems and assists on special projects. Maintains lot traceability, log sheets, and good housekeeping practices at all times. Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner. Ensure that lab cleanliness and safety standards are maintained. Performs thorough inspections during and after the production process to ensure product quality and compliance with standards. Verifies that all product labeling is accurate, compliant, and meets regulatory requirements. Ensures that production lines are properly cleared and prepared for the next production run, maintaining cleanliness and order. Examines and validates DHRs to ensure all documentation is complete, accurate, and in compliance with regulatory and company standards. Other duties as assigned. What does it take to be successful? High school diploma or equivalent required. Previous experience working in a GMP facility a plus. 8 hours of Quality Training (PTC) required. Strong attention to detail. Knowledge of basic arithmetic and application to solve problems. Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods. Knowledge of computer skills, administrative and office procedures and systems. Communicating effectively in writing as appropriate for the needs of the audience. Technical skills and ability to understand drawings, artworks and procedures. Talking to others to convey information effectively. Perform duties with the highest regard for safety and quality. Ability to understand and follow site protocols, policies and procedures Must be flexible, forward- thinking, motivated, and have the ability to act independently. Ability to prioritize tasks and meet deadlines. Problem-solving skills. Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training. Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred. Our Awesome Benefits Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes: Health Plans Dental Plans Vision Plan 401k with Employer Match Paid Time Off and Paid Holidays Employee Events Wellness Programs Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more EOE/M/F/Vet/Disabled VEVRAA Federal Contractor J-18808-Ljbffr