Complaint Handling

Responsibilities

• Required BS Engineer degree
• Accurately records and logs all complaint information from customers and client employees into the electronic complaint handling database.
• Records and reports complaints to manufacturers of distributed products as stated in distribution agreements.
• Acknowledges receipt of complaint and generates closure letters, as appropriate.
• Assists with complaint reportability determinations (e.g., MDR, Vigilance, etc.).
• Provides information necessary for completion of regulatory reports (e.g., MDR, Vigilance, etc.).
• Assures timely complaint closure, meeting both internal and external requirements and goals, by tracking complaints and samples from the customer thru file closure.
• Completes complaint file closure activities.
• Continuously monitors complaints for potential trends.
• Responsible for the secure and accurate maintenance of the complaint database.

Requirements

• Not looking for a Quality or Lab tech.

Qualifications

• Clear communication skills (the ideal candidate will to communicate with doctors, sales reps and international counterparts via telephone and email).
• Analytical skills/critical thinking
• Attention to detail
• Strong work ethic and time management
• Would prefer a candidate with some medical experience whether job-related or through education; i.e. FDA knowledge, or anatomy, etc.

Skills

• Clear communication skills
• Analytical skills/critical thinking
• Attention to detail
• Strong work ethic and time management
• Medical experience (FDA knowledge, anatomy, etc.)