Medical Device Complaint Specialist

3 weeks ago


Irvine, United States Marquee Staffing - OC Full time $24 - $25
Job DescriptionJob Description

Class III Medical Device Manufacturer is looking for a complaint specialist. 

Temp to hire (4-5 Mo) Fully Covered benefits once converted to full-time.

Shift Options:

  • Swing Shift: 8:00 AM - 4:30 PM
  • OR 9:00 AM - 5:30 PM

Pay Rate:

  • $25/hr

Job Description:

  • Record and evaluate complaint submissions related to medical devices.
  • Communicate with territory managers and clinical specialists to gather relevant information regarding complaints.
  • Coordinate with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and R&D) to integrate vital input into complaint reports.
  • Record and provide regulatory reportability decisions on complaints.
  • Ensure timely processing of complaints.
  • Generate and submit medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations.
  • Respond to inquiries concerning medical device report submissions associated with device malfunctions or serious injuries.
  • Participate in activities to prepare for audits and inspections.
  • Receive returned goods and decontaminate if necessary.
  • Review and prepare complaint files for closure.
  • Contribute to inter-departmental cross-functional projects.

Position Qualifications:

  • Knowledge of medical terms associated with sacral neuromodulation procedures and Medical Device Reporting regulations.
  • Exceptional organizational skills and attention to detail.
  • Ability to perform job functions with minimal supervision and work independently.
  • Flexibility and a positive outlook in handling new processes, technology, and general changes.

Minimum Education:

  • Bachelor’s degree or higher preferred.
Company DescriptionMarquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.

Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.

Apply with us todayCompany DescriptionMarquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.\r
\r
Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.\r
\r
Apply with us today
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