KARL STORZ is currently looking for a Complaint Handling Specialist. This position acts as a primary contact for receiving, processing, investigating, documenting and monitoring trends 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.

Responsibilities

• Maintains the problem log to record and identify recurring issues and report these to the Senior Manager, Post Market Surveillance. This includes recording, reviewing and approving incoming complaints, assigning investigation responsibility, conducting investigations and reporting problems to applicable manufacturers, identifying trends, etc.
• Collaborates with other internal groups to respond to product inquiries and issues.
• Answers telephone, email or written inquiries regarding complaints.

• Manages assigned complaints, conducts investigation, enters evaluation codes and closes complaints in a timely manner.
• Applies company policies and procedures to resolve a variety of issues.
• Develops knowledge on product specialties assigned.
• Creates trending reports.
• Provides and assists 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.
• Tracks and prepares 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 utilizes appropriate resources, e.g., Marketing, R&D, Tech Support, Manufacturer, Sales Force, FSTs, OES's, and customer, to properly investigate complaints.
• Builds productive internal/external working relationships
• Continuously contributes to process improvements

Required

• High School Diploma or equivalent
• 1-2 years of related Quality or Complaint handling experience; or equivalent work experience
• Knowledge of SAP transactions relating to complaints and product information

• Strong organizational skills; ability to be pro-active, multitask efficiently, complete tasks on time, and handle deadlines under pressure
• Familiarity with Word, PowerPoint, and Excel
• Ability to work both independently and as part of a team
• Excellent verbal and written communication skills and interpersonal skills

• Ability to exercise discretion and confidentiality with sensitive patient/company information.
• Ability to grasp concepts and be a quick study
• Ability to build Internal/External customer relationships
• Must be able to maintain productive working relationships, treat fellow employees with respect, and possess high ethical standards.

Preferences

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

• Experience participating in internal or external audits.
• KARL STORZ product knowledge

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