About this role
<div> <h2><strong>About KARL STORZ</strong></h2> <p>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.</p> <p> </p> <p>As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients’ lives around the world.</p> <hr> <h2> </h2> <h2><strong>About the Role</strong></h2> <p>At KARL STORZ, quality and patient safety are at the core of everything we do. As a <strong>Complaint Specialist</strong>, you will play a critical role in ensuring product quality and regulatory compliance by managing the full lifecycle of product complaint investigations.</p> <p> </p> <p>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.</p> <p> </p> <p>This role is ideal for a detail-oriented professional with strong analytical skills who is passionate about quality systems, compliance, and improving patient outcomes.</p> <hr> <h2> </h2> <h2><strong>What You’ll Do</strong></h2> <ul> <li>Manage end-to-end product complaint investigations, including intake, documentation, evaluation, and closure</li> <li>Review and assess incoming complaints, assign investigation ownership, and ensure timely resolution</li> <li>Conduct complaint trending and reporting to identify product or process improvement opportunities</li> <li>Prepare and submit regulatory reports (e.g., MDR/MPR) in compliance with FDA and global requirements</li> <li>Collaborate with internal teams and external partners to gather technical information and resolve issues</li> <li>Support audits and ensure adherence to quality systems, SOPs, and complaint handling procedures</li> </ul> <hr> <h2> </h2> <h2><strong>What You Bring</strong></h2> <ul> <li>4–6 years of experience in quality, complaint handling, or a related field</li> <li>High school diploma required; bachelor’s degree or quality certification preferred</li> <li>Knowledge of FDA regulations, complaint handling guidelines, and quality systems (GMP, ISO)</li> <li>Experience with SAP or similar systems for complaint tracking and product data</li> <li>Strong written and verbal communication skills with the ability to document clearly and accurately</li> <li>Excellent organizational skills with strong attention to detail</li> </ul> <p> </p> <p><strong>Nice to Have:</strong></p> <ul> <li>Experience preparing and submitting MDR/MPR reports</li> <li>Background in medical device, healthcare, or regulated industries</li> <li>Familiarity with KARL STORZ products or similar technologies</li> <li>Experience supporting audits (FDA, ISO, or third-party)</li> </ul> <hr> <h2> </h2> <h2><strong>What Will Make You Successful</strong></h2> <ul> <li>Strong analytical and problem-solving skills with the ability to evaluate technical information</li> <li>High level of accuracy and attention to detail when managing sensitive complaint data</li> <li>Ability to work independently while collaborating effectively across teams</li> <li>Sound judgment and discretion when handling confidential information</li> <li>A proactive mindset with a drive for continuous improvement and process optimization</li> </ul> <hr> <h2> </h2> <h2><strong>Why KARL STORZ?</strong></h2> <p>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.</p> <p> </p> <p>We invest in our employees’ development and provide opportunities to grow within a global MedTech leader committed to innovation, integrity, and continuous improvement.</p> <p> </p> <p><strong>Ready to make an impact?</strong> Apply to be our next <strong>Complaint Specialist</strong> and help us build the future of MedTech together.</p> <p> </p> <p>#LI-AA1</p> </div>