Complaint Handling NA Specialist III
About The Position
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.
Requirements
- 4–6 years of experience in quality, complaint handling, or a related field
- High school diploma required
- 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 Haves
- 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)
Responsibilities
- 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
Benefits
- Opportunities to grow within a global MedTech leader committed to innovation, integrity, and continuous improvement.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
