Quality System Manager

ZEISS Meditec Inc.; Dublin (CA); On-site; USD 132,200 - 165,300; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS Meditec Inc. in Dublin, CA, seeks a Quality Systems Manager to lead the development, implementation, and maintenance of the company’s QMS to ensure medical device regulatory compliance.

You will oversee audits, CAPA, document control, change management, and supplier liaison activities, driving continuous quality improvements. The role requires a strong background in ISO 9001:2015, 21 CFR Part 820, and ERP/IT system integration; expect cross-functional collaboration and documentation

Qualifications

• Bachelor's degree preferred in quality, business administration, or a scientific field.
• Minimum ten years' experience with quality management systems for medical devices.
• Knowledge of 21 CFR Part 820 and ISO 9001:2015 requirements.
• Experience with enterprise IT systems from a QMS perspective (ERP/SAP, CRM, SharePoint).

Responsibilities

• Develop and implement QMS processes, systems, and procedures at SSC level per ISO 9001:2015.
• Guide process owners to maintain compliant QMS and standardize procedures.
• Create and maintain QMS documentation, forms, and records.
• Coordinate OEM document center changes and deviations with proper signatures and file management.
• Prioritize and facilitate approval of change orders.
• Keep SOPs and guidance documents up to date.
• Run validation-related documentation and ensure compliance with regulations.
• Support end-users in using document and records systems.
• Manage local DMS workspaces and training for QMS.
• Support audits, CAPA, and NC processes; lead internal audits.

Skills

Project management

Communication

Adaptability

Regulatory knowledge

Education

Bachelor's degree in quality or related field

Tools

SAP

CRM

Agile

SharePoint

Job description

Quality Systems Manager

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.

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.
• Manage local Document Management System (DMS) workspaces.
• Support 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, on‑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.

Do you qualify?

• 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. Experience in ERP systems, such as SAP, CRM, Agile and SharePoint is desired.
• Strong Project Management skills.
• Excellent oral and written communication skills.
• Ability to adapt quickly to change and work in a rapidly changing environment.
• The annual pay range for this position is $132,200 - $165,300.

This position is eligible for a Performance Bonus.

ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

Benefits

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

Zeiss provides 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 of the employee (or the people with whom the employee associates, including relatives and friends).