Complaint Handling Specialist I
El Segundo, CA, US, 90245
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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KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Los Angeles