Quality Assurance Inspector - Medical Devices (GMP)

Extremity-Care; San Diego (CA); On-site; USD 55,000 - 75,000; Full time

Job summary

Extremity-Care is seeking a Quality Inspector in San Diego to determine product conformance to drawings, SOPs and regulatory standards. You will inspect, measure and test components, maintain records, and approve materials for release in a clean-room environment, with potential NCR/CAPA involvement and occasional lifting.

The role requires a high school diploma and at least 3 years in Medical Devices or Pharmaceuticals, plus the ability to work independently or in a team and to adapt to FDA GMPs

Qualifications

• Reading and interpreting mechanical drawings and specifications.
• Knowledge of FDA Quality System Regulation GMPs.
• Ability to function in an FDA regulated environment.
• Ability to perform basic arithmetic with measurements.
• Excellent written and oral communication abilities.
• Work both independently and in a team.
• Maintain high ethics and integrity at all times.
• Capable of multi-tasking in a fast-paced setting.
• Proficient with MS Office and related software.

Responsibilities

• Inspect, measure and test product materials per specs and SOPs.
• Perform incoming, in-process and finished product inspections and record results.
• Use calipers, gage, CMM, microscope and other devices to verify conformance.
• Work in a clean room with gowning requirements.
• Generate NCRs for corrective actions and disposition non-conforming products.
• Maintain inventory log of product retains.
• Perform and document Device History records and releases.
• File and maintain procedures-compliant records.
• Evaluate product returns for complaints, including related NCR/CAPA issues.
• Back up departmental needs as required.
• Occasionally lift up to 25 pounds and attend shifts as needed.
• Stay current with FDA 21 CFR 1271, 820, ISO, cGMP/CGTP, and internal policies.

Skills

Reading drawings

FDA GMP knowledge

FDA regulated environment

Mathematical measurement

Effective communication

Independent and teamwork

Ethical standards

Multitasking

MS Office proficiency

Education

High school diploma or equivalent

Job description

Extremity-Care is seeking a Quality Inspector in San Diego to determine product conformance to drawings, SOPs and regulatory standards. You will inspect, measure and test components, maintain records, and approve materials for release in a clean-room environment, with potential NCR/CAPA involvement and occasional lifting.

The role requires a high school diploma and at least 3 years in Medical Devices or Pharmaceuticals, plus the ability to work independently or in a team and to adapt to FDA GMPs