Complaint Handling Coordinator Job in Elyria 44035, Ohio US

Industry Leader on the West Side of Cleveland is currently recruiting for a Complaint Handling Coordinator.

 

BASIC FUNCTION:

 

 

This position is responsible for maintaining quality processes associated with customer complaint handling, including ensuring completeness and consistency of documentation, handling follow up on complaint information, communicating with other departments, and timely closures.

 

 

ESSENTIAL FUNCTIONS:

 

 

·   Receive incoming customer calls, faxes, and emails, and ensure all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions

 

·   Review documentation for completeness and consistency and execute additional actions as necessary to close or determine appropriate disposition of the complaint file

 

·   Perform the preliminary classification of the complaints and elevate complaints that require reporting for additional review

 

·   Maintaining oversight of the Issue / Complaint Handling daily processes to ensure issues are being addressed in a timely and compliant manner

 

·   Prepare responses to customer requests for failure analysis as necessary

 

·   Develop, prepare, and analyze trend reports for complaints on a weekly and monthly basis, as required

 

·   Ensure compliance with the company?s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies

 

REQUIRED EXPERIENCE, SKILLS QUALIFICATIONS:

 

·         High School Diploma or Associate degree

 

·         Minimum (1) one to (3) years of product complaint or medical documentation experience; medical device experience preferred

 

·         Organized and details oriented; proven ability to meet deadlines

 

·         Strong analytical skills; verbal, and written communication skills

 

·         Ability to work individually and as part of teams

 

·         PC knowledge to include MS Word, Excel, PowerPoint, Access Visio, and database management

 

·         Ability to work various shifts between 8 a.m. and 8 p.m.

 

 

PREFERRED QUALIFICATIONS:

 

·   Bachelors degree in science or engineering

 

 

Job Experience:
1-3 Years