Complaint Handling NA Specialist III

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. MA Applicants It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Medical / Dental / Vision including a state‑of‑the‑art wellness program and pet insurance, too! Up to 8 weeks of 100% paid company parental leave; includes maternal / paternal leave, adoption, and fostering of a child. 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits) Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance We prepay your tuition up to $5,250 per year! – Tuition pre‑reimbursement Fitness reimbursement of up to $200 annually And much more! Safety & Credentialing 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. #J-18808-Ljbffr KARL STORZ SE & Co. KG