Posted in Other 30+ days ago.
Job ID |
2021-2482 |
Location |
US-CA-Irvine |
Category |
Quality |
Overview
Job Scope:
This position is responsible for the ongoingcomplaint handling and device reporting for Endologix products which are distributed internationally. This includes assessing and determining reportability, collecting relevant information about the complaint, conducting complaint investigation, and documenting the various elements within a comprehensive report per established procedures.
Responsibilities
Major Duties:
Qualifications
Education:
Minimum Education: |
|
Bachelor's degree in a scientific discipline or equivalent. Consideration will be given to candidates that have 5-7 years' experience in complaint handling within the Medical Device Industry. | |
Minimum Experience: |
|
* Minimum of 5-7 years of experience in complaint handling in the Medical Device industry. * Extensive knowledge of medical device regulations. * Comprehensive knowledge of quality systems and relationship to business. * Ability to facilitate and provide leadership concerning customer complaint investigations. * Must demonstrate technical writing ability. * Good interpersonal skills including ability to interact with high degree of diplomacy. * Ability to work in a fast-paced, technically challenging environment where drive is critical to success. * Provide leadership concerning investigation activities and facilitate the timely closure of complaint investigations. * Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities. * Effective problem-solving techniques and excellent applied thinking skills. * Strong communication and organization skills required. * Expertise in Microsoft Office applications and charting programs. * Must be willing to perform returned product evaluations on devices that have been exposed to human bodily fluids (perform decontamination and once decontaminated) * Have or be willing to receive appropriate series of vaccinations for Hepatitis B. |
Environmental Resources Management Inc |
Environmental Resources Management Inc |
Environmental Resources Management Inc |