Representative,QualityUnit(QSManager)

**How many companies can say they’ve been in business for over 179 years?** Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team! **What 's the role?** The successful candidate will serve as the designated **Quality Unit representative** with oversight of the Quality Management System (QMS) for a diverse portfolio of regulated products (OTC sterile eyedrops, dietary supplements, cosmetics). As a Label Owner/Distributor, this individual does not manufacture but holds ultimate responsibility for product quality, regulatory compliance, and release. This role also manages the Tier 2 Customer Care function, serving as the escalation point for quality complaints, medical inquiries, and Adverse Event Reporting (AER), working closely with the local Tier 1 Customer Service team. **Sound Interesting? Here 's what you'll do:** **1\. Quality Management System (QMS) Oversight** * **Maintain QMS:** Develop, implement, and maintain a robust QMS compliant with **21 CFR 210/211** (Drugs), **21 CFR 111** (Supplements), and **MoCRA/ISO 22716** (Cosmetics). * **SOP Management:** Author and approve Standard Operating Procedures (SOPs) regarding document control, change control, deviations, CAPA (Corrective and Preventive Actions), and product recall strategies. * **Training:** Ensure all employees (including Tier 1 CS staff) are trained on relevant GMPs, GDPs (Good Distribution Practices), and complai