Position       : Customer Advocacy Clinical Specialist    

Location : San Diego, CA

Duration : 12 Months Contract

Total Hours/week :40.00

must work on site M-F 8-5 (may have some flex in start/end time by 1 hour no guaranteed)

Description:

must have:

• attention to detail
• excellent written skills
• must be meticulois
• ability to work under pressure
• Quality Control / Auditing with a knack for technical info and the incredible attention to detail

• will be reviewing complaint records back to 2015 and updating the records per new guidelines
• will require strict adherence to a protocol and contacting customers via email.
• will require meticulous documentation and tracking of records reviewed.
• Experience with quality review / auditing in a highly regulated environment preferred
• must be local to San Diego, (Orange County is too far)

Duties & Responsibilities:

• This job description does not promise or imply that the functions & responsibilities listed are the only duties or responsibilities to be performed or that the position may not change or be eliminated.
• Employees are always expected to follow their supervisors’ instructions and to perform the tasks requested by their supervisors.
• Responsible for the completion of all tasks associated with the project for the complaint files remediation that include reviewing complaint records, electronic complaint record updates, and contacting customers for complaint associated information.
• Must be meticulous / detail oriented, agile, and have good documentation skills.
• Experience in a medical device or other highly regulated field and quality review/auditing are preferred.

Duties & Responsibilities include any of the following as assigned by your Supervisor:

• with the site Quality System Collaborate with appropriate clinical, technical, and/or regulatory employees to understand the scope of the project and recognize the level of the file remediation
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
• Coordinate and prepare project updates throughout the project
• Comply

• Performs other duties as assigned.

Minimum Qualifications:

• Associates degree or high school education preferred: a minimum of 1 year experience in Quality, Regulatory or Complaint management; or equivalent combination of education and experience.
• Working knowledge of QA in a medical device industry.
• Good English grammar and writing skills.
• Attention to details and complete documentation.
• Time management skills, adherance to schedules
• Able to utilize computers for development of reports and summary of project experience including word processing, graphics and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel.
• Prior work with TrackWise Complaint Handling System or equivalent electronic complaint database preferred.
• Ability to work on multiple files with various disciplines are essential. Position requires ability to solve problems and meet deadlines.