Manager Quality Control

JOB REQUIREMENTS: Job Information Number ICIMS-2026-11001 Job function Other Job type Full-time Location Werfen - Waukesha - Waukesha, Wisconsin United States Country United States Shift 1st About the Position Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Manager, Quality Control is a key contributor to the Quality Assurance and Regulatory Affairs (QARA) team for the Transplant Technology Center. Reporting to the Sr. Director Quality Assurance and Regulatory Affairs, this role will be responsible for leading the Quality Control team and all is responsible for all other aspects of the Quality Control Department. Responsibilities Key Accountabilities Leads the Quality Control (QC) team, providing strategic direction and day-to-day leadership, including setting clear, challenging, and achieveable SMART goals for the team, aligning individual and department goals with broader business unit strategy, prioritization of work, resource allocation, workforce planning and talent management, including hiring, onboarding, training, performance management to build a high performing team. Partners cross-functionally with Quality Assurance, Regulatory Affairs, Research & Development, Manufacturing Technical Support and Operations to resolve issues, support product development and ensure alignment. Ensures QC team team and site adherence to SOPs, FDA, Regulatory and Compliance (ISO 13485, 21 CFR 820, and MDSAP Requirements) and good manufacturing practices to ensure inspection readiness and audit compliance, while fostering a culture of accountability and quality excellence. Role models and reinforces company values, driving a high performance, collaborative, and inclusive team environment. Drives continuous process improvments and operational efficiency within the department, proactively identifying opportunities to... For full info follow application link. Werfen is an Equal Employment Opportunity company, committed to selecting, promoting, and compensating individuals regardless of race, religion, sex, age, national origin, or qualifiable disability. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/E606A80359754C3B