I. Job Purpose and Core Tasks
This position is responsible as a primary notification and consolidation point for receiving, processing, trending and reporting product complaints. Trends problem log to identify and report recurring issues to Senior Manager, Post Market Surveillance. Updates complaint procedures to ensure capture current practice and investigation of complaints. 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 and approving complaints, reviewing incoming complaints, assigning investigation responsibility, conducting investigations and reporting problems to applicable manufacturers, identifying trends, etc. and conduct follow ups on potential MDR/MPR reportable events. May collaborate with other internal groups to respond to product inquiries and issues via telephone, email or written inquiries.
II. Minimum Knowledge, Education and Skill Requirements
Required
Minimum years of relevant work experience:
- 3-5 years of related Quality or Complaint experience; or equivalent work experience
Minimum education, certifications and/or credentials:
- A minimum education level of High School Diploma or related Quality certifications
- Minimum hard skill requirements (including computer and application proficiency):
- Knowledge of SAP transactions relating to complaints and product information
- Ability to be pro-active
- Ability to write clear, concise and error-free documents
- 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
- Excellent 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
- Strong computer and organizational skills
- Ability to build Internal/External customer relations.
Preferred
Preferred years of relevant work experience:
- 3-5 years of related Quality or Complaint experience
Preferred education, certifications and/or credentials:
- Bachelor's degree and a minimum of 3 years of related experience
- Preferred hard skill requirements:
- Problem solving skills
- KARL STORZ product knowledge
- Knowledge of Quality Management Systems or complaint handling
- Knowledge of SAP transactions relating to complaints and product information
- Knowledge of FDA and ISO Regulations, Complaint Handling Guidelines, GMPs, and/or familiarity with standard operating procedures
Preferred soft skill requirements:
- Participate in FDA; TUV; or 3rd Party Audits.
III. Essential Functions
- Must be able to maintain productive working relationships, treat fellow employees with respect, and possess high ethical standards.
- Has contact with: Director, Product Liability; International Complaint handling; Marketing and internal and external KS customers in North America.
- Physical requirement/Demands: Ability to multitask efficiently, complete tasks on time, and handle deadlines under pressure.
- Develop knowledge on product specialties assigned
- Conduct 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
- Frequent use and general knowledge of industry practices, techniques, and standards to develop solutions to a variety of problems of moderate scope and complexity.
- Conducts medical event follow ups with medical facility personnel including physicians and nurses and documents MDR/MPR follow up conversation in complaint files.
- Completes assigned potential medical incident tasks related to MDR/MPR activities
- Investigational duties include the ability to locate technical information and working with all sources, e.g., Marketing, R&D, Tech Support, Manufacturer, Sales Force, FSTs, OES's, and customer to properly investigate complaints.
- Manages assigned complaints, conducts investigation, enters evaluation codes and closes complaints in a timely manner.
- Recommends and helps implement corrective actions when necessary
- Mental requirements/Emotional Demands: N/A
- Interpersonal and communication skills:
- Builds productive internal/external working relationships
- Continuously contribute to process improvements
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors
- Refers to policies and practices for guidance