Zeiss Group

Quality Manager, Consumer Health Products

Hebron, KY

Sponsorship not specifiedDetected 16 days ago

AuditingSupply ChainLogisticsCustomer SupportGMPFDA RegulatoryMedical DevicesResearchCommunicationInternal AuditRegulatory Affairs

About the role

How many companies can say they've been in business for over 179 years?
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.

Provide direct quality oversight of local warehousing, 3PL partners, distribution processes, transit temperature monitoring, and controlled room temperature (CRT) storage programs.
Manage local quality activities related to product hold, release, rejection, escalation, and recall readiness.
Partner with Operations and external logistics partners to identify quality risks, resolve issues, and drive continuous improvement.
Maintain practical, inspection-ready Quality Management Systems (QMS) for assigned regulated products and distribution activities.
Manage key QMS processes, including document control, change control, deviations, CAPA, complaints, training, supplier quality, and recall readiness.
Author, revise, and implement Standard Operating Procedures (SOPs), work instructions, forms, and training materials.
Lead site readiness for FDA, customer, supplier, and internal audit activities.
Track quality metrics, identify trends, and drive continuous improvement.
Work with Supplier Quality, Regulatory Affairs, Operations, and external manufacturers to maintain effective CMO and supplier oversight.
Support supplier qualification, audit readiness, audit follow-up, quality agreements, and supplier CAPA tracking.

Technical Review: Ability to review technical quality documentation, identify risks and gaps, and drive required follow-up.
Communication: Strong written and verbal communication skills with the ability to translate regulatory and quality expectations into clear procedures, training, and business processes.
5+ years of experience in Quality Assurance, Quality Systems, Supplier Quality, Regulatory Affairs, or Compliance within an FDA-regulated industry.
Ability to review technical quality documentation, identify risks and gaps, and drive required follow-up.
Strong written and verbal communication skills with the ability to translate regulatory and quality expectations into clear procedures, training, and business processes.
Support product disposition activities by ensuring required documentation is complete, accurate, and aligned with specifications and quality agreements.

Direct experience with OTC drug products, sterile ophthalmic products, controlled room temperature distribution, temperature monitoring, or cold-chain distribution models.
Familiarity with 21 CFR 210/211, 21 CFR 111, MoCRA, ISO 22716, or related distribution quality and stability standards.
Experience with CMO oversight, quality agreements, supplier audits, and supplier CAPA.
Experience reviewing sterility assurance records, environmental monitoring summaries, media fill summaries, or aseptic processing documentation.
ASQ CQA, ASQ CQM/OE, RAC, or related professional certification.
RAC (Regulatory Affairs Certification / Training)
CQA (Certified Quality Auditor by ASQ)
CQM/OE (Certified Manager of Quality/Organizational Excellence)

Practical, risk-based quality judgment.
Strong ownership and operational follow-through.
Ability to operate effectively in an outsourced manufacturing and physical distribution model.
Strong organization and documentation discipline.
Ability to balance compliance requirements, business needs, and patient/customer protection.
A continuous improvement mindset.

Vacation and sick pay from your first day
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.
ZEISS is looking for a hands-on Quality Manager to help support and scale our growing regulated consumer health portfolio, including OTC sterile eye drops, dietary supplements, cosmetics, and related products.

Here at ZEISS, we certainly can!
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!

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

This listing is sourced directly from Zeiss Group's careers page and normalized into a canonical job model.