Argen Corporation
3 weeks ago Be among the first 25 applicants
This range is provided by Argen Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $18.25/hr - $20.00/hr
Quality Assurance Inspector I
Monday - Friday, 8:30am - 5:00pm
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
Seniority level Entry level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Argen Corporation by 2x
Get notified about new Quality Assurance Inspector jobs in
San Diego, CA .
#J-18808-Ljbffr
This range is provided by Argen Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $18.25/hr - $20.00/hr
Quality Assurance Inspector I
Monday - Friday, 8:30am - 5:00pm
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
Seniority level Entry level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Argen Corporation by 2x
Get notified about new Quality Assurance Inspector jobs in
San Diego, CA .
#J-18808-Ljbffr