Complaint Handling NA Specialist III

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.

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.

• 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

• 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)

• 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

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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