Associate Complaint Management Specialist
26 Technology Drive Irvine, CA 92618 US
Job Description
Associate Complaint Management Specialist
Mon-Fri 8:00am-5:00pm
Pay: Up to $24/hr
General Description and Duties:
The Associate Complaint Management Specialist is responsible for supporting the required event reporting and investigation of all medical device complaint-related procedures, in accordance with applicable laws and regulations.
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Key Responsibilities:
- Record and evaluate complaint submissions.
- Communicate with territory managers and clinical specialists to acquire relevant complaint information.
- Coordinate with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and R&D) to incorporate 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 regarding medical device report submission associated with device malfunction or serious injury.
- Participate in activities to prepare for audits and inspections.
- Receive returned goods and decontaminate them if necessary.
- Review and prepare complaint files for closure.
- Participate in inter-departmental cross-functional projects.
Projects and Other Duties:
- Perform other duties as assigned by supervisor.
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.
- Display flexibility and a positive outlook in handling new processes, technology, and general change.
Minimum Education:.
- Bachelor’s degree or higher preferred.
Minimum Experience:
- 3 years of related work experience.
Meet Your Recruiter
Emily Munoz
Senior Recruiter
As Senior Recruiter, Emily works on finding qualified candidates for medical device and aerospace industry as well supporting our clients as account manager. Emily focuses on finding the right people for her clients and the right fit for her candidates. Emily graduated from California State Polytechnic University, Pomona with a degree in Hospitality Management, Prior to working as a recruiter, Emily worked managing coffee shops for over 10 years. Emily uses her customer service skills and background to help people find their ideal work environment.
During her off time, Emily enjoys cooking, baking and spending time with her husband, two sons and her dog Rosie.