What are the responsibilities and job description for the Quality Assurance Inspector I position at Argen Corporation?
Quality Assurance Inspector I
Monday – Friday, 1:30pm- 10:00pm
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
Salary : $20 - $22