Quality Assurance Inspector I

Quality Assurance Inspector I

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.

Essential Duties and 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.

Experience & 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 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