Complaints Specialist

Complaints Specialist

27 Oct 2024
California, San diego, 92101 San diego USA

Complaints Specialist

Vacancy expired!

Complaints Specialist
Duration: Until end of year and extendable
Location: San Diego., CA

Description:
This is a Complaints Specialist position for IGT Devices; part of the business group. In this role, you have the opportunity to work with cutting-edge medical device product lines!

SUPPLIERS - When you interview people, you will need to set the expectation that phones will be a major part of the day to day operations of this role.

To succeed in this role, we look for the following skills and experience:
o Bachelor's degree preferred
o Prior complaint handling experience in a medical device industry
o Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting, The Privacy Rule, HIPAA, ISO 13485)
o Demonstrated experience meeting performance requirements
o Solid experience with use of word processing, spreadsheet, database and presentation applications
o Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.

As a part of our team, you may be responsible for any of the following:
o On Phone extensively daily
o Day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives.
o Receipt of initial complaint from any source (external and internal) and ensuring all information/data is accurately captured at point of contact. You may triage calls from various sources for complaints, request for refund, request for replacement product and request for credit.
o Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.
o Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation. May compose and/or submit Medical Device Reports.
o Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner in a high volume, fast paced setting per requirements and directives.
o Reviewing record documentation and follow-up activities for completeness and timeliness.
o Closing files according to established guidelines to meet required timelines.
o Maintaining a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions, Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures.
o Demonstrating the Philips Behaviors at all times.
o Informing management of potential safety issues, emerging trends and/or concerns.

Regards

Daya Poojary
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560

Direct: 510-857-5736
PhoneExtn. 124
Fax: 510-623-5055

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Job Details

  • ID
    JC5243489
  • State
  • City
  • Job type
    Contract
  • Salary
    $20 - $30
  • Hiring Company
    APN Software Services, Inc
  • Date
    2020-10-05
  • Deadline
    2020-12-03
  • Category

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