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Regulatory Affairs/Quality Assurance Specialist

Company Name: Passy-Muir, Inc.
Location: Irvine, CA
Job Type: Contract-to-Hire or Direct Hire
Contact Name: Mary Sarris
Phone: 949-833-8255
Fax: 949-833-8299
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: $60,000 - 80,000 CWE

Job Description 

  • Develops and maintains the Quality Management System in accordance with regulatory and corporate requirements
  • Works closely with production facility to ensure adequate quality controls are undertaken
  • Assists with verification activities
  • Assists with customer complaints/CAPA system
  • Tracking and trending of out-of-specification results, failure investigation, deviations, change controls (equipment and document) and complaints
  • Approval and release of Quality Records, Device History Records, Master Labels and Device Master Records
  • Monitoring and verification of qualification and validation processes to ensure compliance with written protocols and regulatory requirements
  • Development of risk assessment review process for all marketed devices and implementation of changes to risk management process as needed
  • Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions
  • Development of controlled documents and procedures pertinent to Quality Assurance activities
  • Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development
  • Participates in the Corrective and Preventive Action System, Non-conformance System, internal and external audits, labeling review and regulatory submissions globally, and document changes within the Document Control System

Job Requirements 

  • Minimum 5+ years’ experience in medical device manufacturing environment
  • Experience with ISO 13485 / 21 CFR 820 required
  • Experience with Class II FDA 510(k) submissions strongly preferred
  • Risk management process experience necessary
  • Risk management procedure and project management experience desirable
  • Strong communication & documentation skills necessary
  • Flexibility and adaptability
  • Ability to work in a team environment, strong organization and leadership skills
  • ASQ Certification for Certified Quality Manager or Certified Quality Auditor is a plus