Associate Complaint Management Specialist

Irvine, CA 92618

Employment Type: Contract to Hire Industry: Medical Device Job Number: 17000 Pay Rate: $20/hr - $25/hr BOE

Job Description

The Associate Compliant Management Specialist is responsible for supporting the required event reporting and investigation of all medical device complaint-related procedures.

Swing Shift:
8am - 4:30pm
9am - 5:30pm

Pay Rate: 

Job Description: 
  • Records and evaluates complaint submissions
  • Communicates with territory managers and clinical specialists to acquire relevant complaint information 
  • Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing and R&D) to incorporate vital input into complaints reports 
  • Records and provides regulatory reportability decisions on complaints 
  • Ensures timely processing of complaints 
  • Generates and submits medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations
  • Responds to inquiries regarding medical device report submission associated with device malfunction or serious injury 
  • Involved in activities to prepare for audits and inspections 
  • Receives returned goods and decontaminates if necessary 
  • Reviews and prepares complaint files for closure 
  • Participates in inter-departmental cross-functional projects 

Position Qualifications: 
  • Knowledge of medical terms associated with sacral neuromodulation procedure and Medical Device Reporting regulations 
  • Exceptional organizational skills and attention to detail 
  • Able to perform job function with minimal supervision and work independently 
  • Display flexibility and a positive outlook in handling new processes, technology and general change 

Minimum Education: 
  • Bachelor's degree or higher preferred 


Meet Your Recruiter

Erika Castro

Erika Castro is a recent graduate from Chapman University, where she majored in Sociology and minored in Latinx and Latin American Studies. As a Recruiter at Marquee Staffing, she specializes in manufacturing and production roles within the medical device industry. Her previous recruiting experience involved working for the state of California to fill open seasonal positions.

In her free time, Erika enjoys hiking the nearby hills, traveling to San Francisco and Mexico, and reading the newest book that has caught her interest.

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