Complaint Handling Specialist (#11-58211) AccessClosure

SUMMARY/RESPONSIBILITIES:



SUMMARY: The Complaint Handling Specialist oversees the company's incident reporting (Complaint Handling) system. Maintain procedures and policies required to manage and investigate complaints, while maintaining compliance with applicable Quality System requirements and FDA regulations.



ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

Maintain standards, methodology, and workflows for the complaint management system. Responsible for special projects related to the complaint handling process.
Review the documentation and investigation of all complaints concerning medical devices.
Monitor complaint data and prepare reports on quality concerns/trends identified through complaints as necessary to management for review.
Assure timely completion and database input of complaint investigations and records.
Follow up with internal and external sources as necessary to ensure complete documentation of complaint related information.
Notify management of situations that may require regulatory reporting and/or potential product recall.
Manage and update complaints database and hard copy files (where necessary) for tracking of complaints.
Prepare and manage complaint documentation, from initial complaint record and description, to as received conditions, investigation records, complaint conclusions, and complaint closure. Maintain complaint history records.
Initiate Return Material Authorization for product return, and coordinate with the sites and field personnel to expedite the return as required. Notify Quality and Receiving of upcoming return, and coordinate with Customer Service regarding warranty replacement if required.
Establish complaint metrics, and report on the metrics on a periodic basis, no less than on a monthly basis, or more frequently if conditions merit. Ability to recognize and analyze data trends.
Participate in biweekly senior management meeting, providing summaries/updates of recent complaints
Responds to FDA and other regulatory agency requests for trending and analysis
Manage medical device reporting (MDR) to FDA through MedWatch System (form)
Initiate, prepare, and distribute reports related to product complaints. Provide guidance/assistance to associates and specialists as needed.
Participate in training internal colleagues and external partners regarding complaint handling.
Perform final review/closeout of complaints as necessary.
Prepare responses to complainants outlining the results of investigations.
Perform other tasks as required.



EDUCATION/EXPERIENCE:

Bachelor of Science degree and a minimum of 3 years previous related work experience in the medical device or biotech industry, or equivalent combination of education and experience
Healthcare background, preferably in cardiology
Excellent understanding of GCPs and CFRs
Clear and effective communication skills
Excellent interpersonal and organizational skills
Proficiency in MS Word, PowerPoint, and Excel required
Strong problem analysis and resolution skills, must be thorough and detail oriented.
Excellent proofreading, editing, and technical writing skills.
Ability to work within strict deadlines, and work on multiple projects accurately and efficiently.
High attention to detail and accuracy is required
Ability to perform multiple tasks concurrently with accuracy
Experience with data bases, data analysis, statistics



WORK ENVIRONMENT:

Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.



SUPERVISORY RESPONSIBILITIES:

No direct supervisory responsibilities.

Location:	645 Clyde Avenue Mountain View, CA 94043 United States