Complaint Handling Specialist I

I.  Job Purpose and Core Tasks

This position acts as a primary contact for receiving, processing, trending and reporting product complaints. Maintains the problem log to record and identify recurring issues and report these to Manager, International Complaint Handling. Processes, investigates, documents and monitors trending and reporting of product defect complaints assigned in accordance with company guidelines and external regulatory requirements for the handling of customer complaints as mandated by the FDA.

This includes; recording, reviewing and approving incoming complaints, assigning investigation responsibility, conducting investigations and reporting problems to applicable manufacturers, identifying trends, etc. May collaborate with other internal groups to respond to product inquiries and issues. May directly answer telephone, email or written inquiries regarding complaints.

II. Minimum Knowledge, Education and Skill Requirements

Required

Minimum years of relevant work experience:

• 1-2 years of related Quality or Complaint handling experience; or equivalent work experience

Minimum education, certifications and/or credentials:

• A minimum education level of High School Diploma

• Minimum hard skill requirements (including computer and application proficiency):

• Knowledge of SAP transactions relating to complaints and product information

• Ability to be pro-active.

• Must be familiar with Word, PowerPoint, and Excel

• Must be able to work both independently and as part of a team.

• Excellent verbal and written communication skills and interpersonal skills

• Minimum soft skill requirements:

• Ability to exercise discretion and confidentiality with sensitive patient/company information.

• Ability to grasp concepts and be a quick study.

• Ability to organize and focus on completion of tasks in a timely manner.

• Ability to build Internal/External customer relationships.

• Strong computer and organizational skills

Preferred

Preferred years of relevant work experience:

• 1-2 years of related Quality or Complaint handling experience

Preferred education, certifications and/or credentials:

• Bachelor's degree and a minimum of 2 years of related experience

Preferred hard skill requirements:

• Problem solving skills.

• Knowledge of Quality Management Systems

• Knowledge of SAP transactions

• Knowledge of FDA and ISO Regulations, Complaint Handling Guidelines, GMPs, and/or familiarity with standard operating procedures

Preferred soft skill requirements:

• Participate in internal or external audits.

• KARL STORZ product knowledge

III. Essential Functions

• Must be able to maintain productive working relationships, treat fellow employees with respect. Possess high ethical standards.

• Has contact with: Director, Product Liability; International Complaint handling; Marketing and internal and external KS customers in North America.

• Manages assigned complaints, conducts investigation, enters evaluation codes and closes complaints in a timely manner.

• Apply company policies and procedures to resolve a variety of issues.

• Develop knowledge on product specialties assigned.

• Create trending reports.

• Provide and assist with incoming complaint requests.

• Exercises judgment within defined procedures and practices to determine appropriate action(s).

• Interacts with other departments, as directed, to complete assigned tasks.

• Tracking and preparing complaint specific information utilizing databases, spreadsheets, and other tools.

• Under close supervision, reviews and participates in the quality assurance of complaint data or documents.

• Investigational duties include the ability to locate technical information and utilize appropriate resources, e.g., Marketing, R&D, Tech Support, Manufacturer, Sales Force, FSTs, OES's, and customer, to properly investigate complaints.

• Physical requirement/Demands: Ability to multitask efficiently, complete tasks on time, and handle deadlines under pressure.

Interpersonal and communication skills:

• Builds productive internal/external working relationships.

• Continuously contribute to process improvements

• Works on problems of moderate scope

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