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Quality Control Support Specialist

2 months ago


Laguna Hills, California, United States Express Employment Professionals- Laguna Hills, CA Full time
Job Overview

Express Employment Professionals is seeking a Quality Control Support Specialist for a contract position with a prominent Medical Device organization.

Compensation: $27 per hour

Key Responsibilities
  • Ensure adherence to the organization's policies, regulatory standards, and legal requirements, including ISO 13485 and FDA 21 CFR Part 820.
  • Maintain and manage Quality Management System (QMS) documentation, ensuring all records are up-to-date and accurately processed.
  • Assist in the upkeep of the Document Master List and medical device files, including document history and external documents.
  • Support the Engineering Change Order (ECO) control process.
  • Keep an updated list of review and approval authorities.
  • Assign new document identifiers and titles as necessary.
  • Help revise existing documentation to meet compliance standards.
  • Ensure adherence to internal document review timelines.
  • Coordinate the processing of new documents and oversee document revision protocols.
  • Assist in managing corrective and preventive actions and handling complaints as required.
  • Review and digitize quality records to confirm their accuracy and completeness.
  • Oversee record retention and off-site storage solutions.
  • Perform additional duties as assigned.

Benefits of working with Express include comprehensive medical benefits, training opportunities, and scholarship programs.