QA/RA Interim Manager

Levittown, NJ

Job ID: 121100 Industry: Quality

QA/RA Interim Manager

Environment:

Our client is a small company that has specialized in the manufacture of single-use and reusable clinical thermometers for infection prevention and reduction. MII’ s products are used in thousands of acute care hospitals, dialysis centers, clinics, long term care facilities, national health services, and physician’ s offices around the world.

Job Duties/Responsibilities:

Maintain the quality system to ensure compliance with all Regulatory and ISO 13485 requirements/certifications. Manage the company' s CAPA program, support product development and manufacturing as necessary, advise management of all significant audit findings, lead internal and external audits, and initiate and execute validation studies

Required:
  • Medical Device
  • QA/RA Compliance
  • Pre-Audit Readiness
  • ISO 13485 – SME knowledge

Desired:
  • Operations experience
  • Local candidate

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