Quality System Manager

ZEISS•Dublin, CA

3d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in quality, or Business Administration, or Scientific field is preferred.
Minimum of ten (10) years of experience working with quality management systems for medical devices.
Knowledge of regulatory requirements for QMS, including, but not limited to, 21 CFR Part 820 quality systems and ISO 9001:2015 is required.
Experience in enterprise IT Systems from a QMS perspective.
Strong Project Management skills.
Excellent oral and written communication skills.
Ability to adapt quickly to change and work in a rapidly changing environment.

Nice To Haves

Experience in ERP systems, such as SAP, CRM, Agile and Share point is desired.

Responsibilities

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 local Document Management System (DMS) workspaces.
Supports special projects for improvements and efficiencies associated with QMS.
Provide QMS support and training as needed for the QMS for the business unit.
Complete a variety of administrative tasks such as assisting with access to change management system access, ordering standards/regulations, and maintaining a standards and regulations library, records retention list, off-site storage list, and weekly report for changes to QMS documents.
Support all department QMS needs including audit preparation & execution activities, requested documentation, training, verification of PLM, MRP and training application system.
Lead, mentor and coach process owners to ensure effective change control including implementation, maintenance and improvement of processes, continued compliance, and process standardization.
Organize, lead, and coordinate internal quality audits, maintain audit schedules, and follow up on audit findings.
Provide the training support as needed with the QMS requirements for this business unit.
Support Internal audits, external audits & facility inspections.
Administer and manage the CAPA and NC system to ensure effective operation.
Oversee validation activities from quality system’s perspective at the SSC level.