Quality Assurance Inspector I

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

Qualifications

• 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

• cGMP
• ISO 13485
• 21 CFR Part 820
• CMDR SOR/98-282
• 93/42/EEC
• RDC 16/2013
• MHLW MO 169
• TG(MD)R Sch3

Benefits

• 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

Location: 8515 Miralani Dr, San Diego, CA 92126
Schedule: Monday–Friday, 8:00am – 4:30pm