Company: KARL STORZ Endoscopy-America, Inc. (KSEA)
Job Code: 12401
Pay Grade: US-C14
Description
KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
KARL STORZ is currently seeking a Complaint Handling Specialist who will be responsible for processing, investigating, documenting and monitoring trending and reporting of product defect complaints in accordance with company guidelines and external regulatory requirements for the handling of customer complaints as mandated by the FDA.
This position will be based at our El Segundo (Los Angeles), CA office with an opportunity to work remote up to 3 days per week.
Key Responsibilities
Key responsibilities will include, but may not be limited to:
- Record and approve complaints, review incoming complaints, assign investigation responsibility and conduct investigations; report problems to applicable manufacturers, identify trends, and conduct follow ups on potential MDR/MPR reportable events
- Collaborate with other internal groups to respond to product inquiries and issues via telephone, email or written inquiries
- Develop knowledge on product specialties assigned
- Conduct trending reports to identify and report recurring issues
- Exercise judgment within defined procedures and practices to determine appropriate action(s)
- Interacts with other departments, as directed, to complete assigned tasks
- Track and prepare complaint specific information utilizing databases, spreadsheets, and other tools
- Under close supervision, reviews and participates in the quality assurance of complaint data or documents
- Update complaint procedures to ensure current practice and investigation of complaints
- 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
- Manage assigned complaints, conducts investigation, enters evaluation codes and closes complaints in a timely manner
- Recommend and help implement corrective actions when necessary
- Build productive internal/external working relationships
Key Requirements
Our successful candidate will have excellent written and spoken business communication skills. They will also have demonstrated success working in a collaborative, service-oriented team environment.
Additional requirements include, but are not limited to:
- High School Diploma or equivalent, or related Quality certifications
- 3-5 years of related Quality, Regulatory or Complaint experience
- Ability to be pro-active
- Strong attention to detail
- Proficiency in Word, PowerPoint, and Excel; familiarity with SAP
- Ability to work both independently and as part of a team
- Excellent verbal and written communication skills
- Excellent interpersonal skills with ability to build internal and external customer relations
- Ability to exercise discretion and confidentiality with sensitive patient/company information.
- Strong organizational skills
- Problem solving skills
Preferred
- Bachelor’s degree and a minimum of 3 years of related experience
- 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
- Experience participating in FDA; TUV; or 3rd Party Audits.
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Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall response to COVID-19.
Employee Benefits Program Overview for U.S. Locations
- Medical / Dental / Vision including a state of the art wellness program and pet insurance, too!*
- 3 weeks’ vacation, 10 holidays plus paid sick time*
- 401K retirement savings plan providing a match of 60% of the employee’s first 6% contribution
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- Tuition reimbursement of up to $5,250 per year
- Fitness reimbursement up to $200 annually
- Employee referral program of up to $2,000 per hire
- And much more!
*Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement
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 TaleoAdministrator@karlstorz.com.
Notice to Employment Agencies
This recruitment assignment is being managed directly by KARL STORZ’s Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required. Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by KARL STORZ Human Resources department will be ineligible for referral fees.
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