Representative, Quality Unit (QS Manager)
Not Disclosed•Full-TimeOn-site
location_onSprucewood Lane, Marydale, Boone County, Kentucky, 41018, United States
About ZEISS
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, we handle ever-changing environments in a fast-paced world, meeting them with cutting-edge 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. As a global company with over 42,000 employees, including over 4,000 in the US and Canada alone, we invite you to make a difference and join our team.
About the Role
This position serves as the designated Quality Unit representative with oversight of the Quality Management System (QMS) for a diverse portfolio of regulated products, including OTC sterile eyedrops, dietary supplements, and cosmetics. As a Label Owner/Distributor, you will not manufacture the products but will hold ultimate responsibility for product quality, regulatory compliance, and release.
In this role, you will also manage the Tier 2 Customer Care function, serving as the primary escalation point for quality complaints, medical inquiries, and Adverse Event Reporting (AER). You will work closely with the local Tier 1 Customer Service team to ensure seamless support and rigorous adherence to safety standards.
Hiring Process
To apply, please submit your resume and cover letter to the ZEISS Recruiting Team. For specific inquiries regarding this position, please contact Christina Choing.
Equal Opportunity Employer
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer. We provide Equal Employment Opportunity without unlawful regard to an Applicant's race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding, or related medical condition), genetic predisposition, carrier status, gender expression or identity (including transgender identity), or any other class or characteristic protected by federal, state, or local law.
Work location
Work model: On-site
Sprucewood Lane, Marydale, Boone County, Kentucky, 41018, United States
Kentucky
Similar Job Opportunities
Skills, education and keywords
Skills: Quality Management System, 21 CFR 210/211, 21 CFR 111, Mocra, Iso 22716, Sop Management, Capa, GMP, GDP, Sterile Assurance.
Education: Bachelor's degree preferred.
Frequently asked questions about Representative, Quality Unit (QS Manager) at ZEISS Group
What does a Representative, Quality Unit (QS Manager) at ZEISS Group do?expand_more
Day-to-day, the Representative, Quality Unit (QS Manager) at ZEISS Group will oversee temperature-sensitive logistics to ensure product integrity during storage and transport; serve as tier 2 escalation point for complex product inquiries and medical questions from tier 1 customer service; manage the intake, evaluation, and reporting of serious adverse events to the fda within mandatory timelines; and monitor complaint trends to identify potential batch failures or emerging safety signals.
What are the requirements for this Representative, Quality Unit (QS Manager) role?expand_more
ZEISS Group is looking for candidates who meet the following requirements: Bachelor's degree preferred; Minimum 7-10 years of experience in Quality Assurance or Regulatory Affairs within Pharmaceutical (OTC) or Dietary Supplement industry; Experience with Sterile Manufacturing or Quality oversight of sterile products; Knowledge of 21 CFR 111 (Dietary Supplements) and 21 CFR 210/211 (Drugs); Experience with Cosmetic regulations (MoCRA); and Experience handling medical information inquiries, complaint investigations, and submitting Adverse Event reports to regulatory bodies.