Company: KARL STORZ North America (KSNA)
Job Code: 12421
Pay Grade: US-C18
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 Manager, Complaint Handling who will be responsible for managing and supporting the implementation of complaint handling processes, including managing a team. This role will work collaboratively with cross functional colleagues in anticipating, addressing, and responding to customer complaints and/or adverse events. In addition, this role will be responsible for MDR/MPR/EU MIR reportable submissions to FDA and Health Canada authorities.
This role will be based at our headquarters in El Segundo (Los Angeles), CA with the opportunity to work remotely 2-3 days per week.
Responsibilities
Key responsibilities will include, but may not be limited to:
- Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging process based upon trending and related analyses.
- Maintains and updates complaint handling and related vigilance operating SOPs and Work Instructions to capture current practice and investigation of complaints and potential adverse events.
- Provides technical expertise to optimize complaint processing systems.
- Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and addressed according to KARL STORZ (KS) complaint handling procedure.
- 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 conducting potential medical incident follow ups.
- Maintains and monitors systems to ensure that all MDR/MPR and EU MIRs are reviewed and received are appropriately investigated and handled per the company’s complaint handling and vigilance procedures.
- May collaborate with other internal groups to respond to product inquiries and issues via telephone, email or written inquiries.
- Ability to read and interpret documents such as product diagrams, safety and health risks, operating and maintenance instructions, and medical procedure manuals.
- Establish and manage processes for effective collaboration with Regulatory, RSB, HR, Legal, Compliance and other KS Departments as required.
- Demonstrates responsiveness and sensitivity to internal/external customer needs. Aligning and partnering with internal and external communications teams and stakeholders globally to ensure consistent communication.
- Provides leadership and development to direct reports.
- Ensure harmonization, and training, on the use of Complaint Handling systems across all North American sites.
Requirements
The 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:
- Bachelor’s Degree or equivalent relevant work experience
- Minimum of 5 – 7 years of experience in Quality or Complaint Handling
- Knowledge of FDA 803; 820, ISO 9001; 13485, CMDR and EU MDR Regulations, Complaint Handling Guidelines, cGMP, and familiarity with standard operating procedures.
- Proficiency with Word, Excel and PowerPoint; working knowledge of SAP and Visio
- Ability to be pro-active and multi-task
- Must be able to work both independently and as part of a team
- Must be able to problem solve and participate in solutions
- Excellent verbal and written communication skills
- Excellent interpersonal, organizational and time management skills
- Ability to exercise discretion and confidentiality with sensitive patient/company information,
- Build and maintain Internal/External customer relations.
Preferred skills
- ASQ, AQS, or BSI related certifications
- KARL STORZ product knowledge
- Knowledge of Quality Management Systems or Complaint Handling
- Knowledge of SAP transactions relating to complaints and product information.
- 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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