Representative, Quality Unit (QS Manager)

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 complaint handling procedures.

2.

Supply Chain Quality & Vendor Management


* Contract Manufacturer (CMO) Oversight: Qualify and audit contract manufacturers.

Ensure Quality Agreements are in place and enforced.


* Sterile Assurance (Eyedrops): specifically review CMO sterility validation data, environmental monitoring summaries, and media fill results before lot release.


* Batch Release: Perform final batch record review and release finished goods for distribution, ensuring products meet all specifications (Identity, Purity, Strength, Composition).


* Warehousing/Distribution: Oversee temperature-sensitive logistics (cold chain or controlled room temperature) to ensure product integrity during storage and transport.

3.

Regulatory Compliance & Labeling


* Label Review: Review and approve product labeling for compliance with FDA "Drug Facts" (OTC), "Supplement Facts" (Dietary Supplements), and cosmetic labeling standards (including MoCRA requirements).


* Product Listing: Maintain FDA facil...