Sr. Field Assurance Specialist

Overview

Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.

Job Scope and Purpose:

This position is responsible for the ongoing complaint 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

• Primary contact for all customer complaint handling and reporting activities related to Endologix products.
• This individual is responsible several aspects of handling product complaints such as:
• Receiving complex medical procedure information (type of procedure performed, types of devices used, patient condition and any complicating factors, etc.) through interaction with Endologix Sale Representatives and internal Endologix systems
• Assessing complaint reportability for the various regulatory agencies within the countries that Endologix products are distributed and reporting within established timelines.
• Investigating complaint information received such as obtaining medical records and images, coordinating retrieval of returned devices and working with customs if necessary.
• Performing and documenting product analysis on returned devices to determine if the root cause for failures can be established.
• Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.
• Develops good working relationships and collaborates with Sales personnel, Customer Service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Representative, distributors and physician users in these investigations.

Maintains current and complete complaint files

Qualifications

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

Experience:

years of related work experience, including:

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.

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