Complaint Handling NA Specialist III
El Segundo, CA, US, 90245
About KARL STORZ
From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.
As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients’ lives around the world.
About the Role
At KARL STORZ, quality and patient safety are at the core of everything we do. As a Complaint Specialist, you will play a critical role in ensuring product quality and regulatory compliance by managing the full lifecycle of product complaint investigations.
In this position, you will serve as a central point for receiving, evaluating, investigating, and trending product complaints—ensuring they are handled in accordance with FDA regulations and internal procedures. You will collaborate cross-functionally with teams such as Quality, Regulatory, R&D, and Customer Support while contributing to continuous improvement of complaint handling processes.
This role is ideal for a detail-oriented professional with strong analytical skills who is passionate about quality systems, compliance, and improving patient outcomes.
What You’ll Do
- Manage end-to-end product complaint investigations, including intake, documentation, evaluation, and closure
- Review and assess incoming complaints, assign investigation ownership, and ensure timely resolution
- Conduct complaint trending and reporting to identify product or process improvement opportunities
- Prepare and submit regulatory reports (e.g., MDR/MPR) in compliance with FDA and global requirements
- Collaborate with internal teams and external partners to gather technical information and resolve issues
- Support audits and ensure adherence to quality systems, SOPs, and complaint handling procedures
What You Bring
- 4–6 years of experience in quality, complaint handling, or a related field
- High school diploma required; bachelor’s degree or quality certification preferred
- Knowledge of FDA regulations, complaint handling guidelines, and quality systems (GMP, ISO)
- Experience with SAP or similar systems for complaint tracking and product data
- Strong written and verbal communication skills with the ability to document clearly and accurately
- Excellent organizational skills with strong attention to detail
Nice to Have:
- Experience preparing and submitting MDR/MPR reports
- Background in medical device, healthcare, or regulated industries
- Familiarity with KARL STORZ products or similar technologies
- Experience supporting audits (FDA, ISO, or third-party)
What Will Make You Successful
- Strong analytical and problem-solving skills with the ability to evaluate technical information
- High level of accuracy and attention to detail when managing sensitive complaint data
- Ability to work independently while collaborating effectively across teams
- Sound judgment and discretion when handling confidential information
- A proactive mindset with a drive for continuous improvement and process optimization
Why KARL STORZ?
Join KARL STORZ and be part of a team dedicated to delivering safe, high-quality medical technologies that improve patient outcomes worldwide. In this role, you’ll contribute directly to product quality and regulatory excellence while working in a collaborative, mission-driven environment.
We invest in our employees’ development and provide opportunities to grow within a global MedTech leader committed to innovation, integrity, and continuous improvement.
Ready to make an impact? Apply to be our next Complaint Specialist and help us build the future of MedTech together.
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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