Medical Device QA Inspector: Precision & Compliance

Extremity Care; San Diego (CA); On-site; USD 55,000 - 85,000; Full time

Job summary

Extremity Care is seeking a Quality Inspector to determine product and material conformance to specifications, drawings, SOPs, and FDA/GMP requirements. Responsibilities include inspecting, measuring and testing materials, documenting results, generating NCRs, reviewing Device History Records, and supporting CAPA investigations.

The role requires a high school diploma, 3 years in medical devices or pharma, ability to work in a clean room, and lifting up to 25 pounds, with proficiency in

Qualifications

• High school diploma or equivalent required.
• 3 years of work experience in Medical Devices or Pharmaceutical Industry; or equivalent education/experience.
• Clearance of favorable background investigation required.

Responsibilities

• Inspect, measure and test product materials in accordance with specifications, drawings, SOPs, and regulatory requirements.
• Document incoming, in-process and finished product inspections and maintain accurate records of results.
• Generate NCRs for corrective action and disposition of non-conforming products and materials.
• Maintain accurate inventory log of product retains and perform Device History Record review and release.
• File and maintain records per SOPs and participate in CAPA investigations.
• Occasionally move or lift up to 25 pounds and work in a clean room with gowning.

Skills

Read drawings

GMP knowledge

FDA regulated env

Math proficiency

Communication

Teamwork

Ethics & integrity

Multi-tasking

MS Office

Education

High school diploma

3 years medical devices or pharma experience

Tools

Calipers

Snap gauge

Coordinate measuring machine

Microscope

Job description

Extremity Care is seeking a Quality Inspector to determine product and material conformance to specifications, drawings, SOPs, and FDA/GMP requirements. Responsibilities include inspecting, measuring and testing materials, documenting results, generating NCRs, reviewing Device History Records, and supporting CAPA investigations.

The role requires a high school diploma, 3 years in medical devices or pharma, ability to work in a clean room, and lifting up to 25 pounds, with proficiency in