Quality System Manager

About Us:

How many companies can say they have been in business for over 178 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it 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.

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!

Location: Dublin, CA

What's the role?

The Quality Systems Manager is responsible for developing, implementing, and maintaining the company's Quality Management Systems (QMS) to ensure compliance with applicable standards.

The primary duties involve overseeing audits, driving initiatives for ongoing improvement, handling CAPA processes, and maintaining document control systems.

The manager fosters a customer focus, collaborates with stakeholders, and ensures timely corrective actions.

Additionally, the Quality Systems Manager serves as a liaison with OEM document centers, overseeing change requests, change orders, and deviations while maintaining documentation accuracy and supporting departmental QMS needs.

This role is essential for ensuring the QMS aligns with relevant regulations and ZEISS global processes.

Sound Interesting?

Here's what you'll do:


* Develop and implement quality management processes, systems, and procedures according to ISO 9001:2015 and other standards at the SSC level.


* Guide, mentor, and support process owners to maintain effective quality management systems by implementing, sustaining, and enhancing processes, ensuring ongoing compliance, and standardizing procedures.


* Create, manage, and maintain essential QMS documentation at the SSC level, including procedures, forms, work instructions, and quality objectives.


* Acts as a liaison for OEM document centers, processing and routing change requests, internal and external change orders, and deviations utilizing required databases including ensuring that the change documentation follows process for signatures and good documentation practices while maintaining accurate documentation and electronic files.


* Facilitate approval process with prioritization of urgent change orders.


* Ensure SOPs, Work Instructions, and guidance documents adequately reflect the work being performed and collaborate for updates to these documents as needed.


* Execute test scripts, write test reports, and perform activities associated with keeping documentation systems compliant with validation/verification requirements and regulations.


* Assist end-users, as needed, to successfully use document and records systems.


* Manages l...