Quality Assurance Inspector I

Job Description

Job Description

???? Join Argen as a Quality Assurance Inspector I????

Location: 8515 Miralani Dr, San Diego, CA 92126
Schedule: Monday–Friday, 5:00am – 1:30pm

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