Job Description
Job Details
Job Location
Elyria, OH
Position Type
Full Time
Job Shift
Day
Description
Summary:
This position is responsible for maintaining quality processes associated with customer complaint handling, including ensuring completeness and consistency of documentation, following up on complaint information, and communicating with other departments.
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 determine appropriate disposition of the complaint file.
Make follow up attempts via phone, email, and fax and/or letter to gather complaint information when necessary.
Maintaining oversight of the Issue / Complaint Handling daily processes to ensure issues are being addressed in a timely and compliant manner.
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.
Develop and display solid computer navigation skills pertaining to company utilized systems.
Additional responsibilities as requested or required.
Complete all required training applicable to assigned position.
Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
Qualifications
High School Diploma required; Associate's or Bachelor's degree in science or engineering preferred.
Minimum (1) one year of product complaint or medical documentation experience or (1) one year experience with Invacare products, systems and/or manufacturing as an associate or temporary worker.
Medical device experience and prior experience with investigation of complaints preferred.
Organized and detail oriented; proven ability to meet deadlines.
Demonstrated ability to build and maintain professional relationships with internal and external partners.
Strong analytical skills and strong verbal and written communication skills.
Ability to work individually and as part of teams.
PC knowledge to include MS Word, Excel, PowerPoint, and database management.
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet
