Quality System Manager

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

Benefits offered by this job

Medical plans

Vision & Dental plans

401k Matching

Employee Assistance Program

Vacation and sick pay

Job summary

ZEISS Group in Dublin, CA is seeking a Quality Systems Manager to develop, implement, and maintain the company’s Quality Management Systems (QMS) ensuring compliance with ISO 9001:2015 and 21 CFR Part 820. You will oversee audits, CAPA, document control, and change processes, acting as liaison with OEM document centers and supporting training across the unit.

The role requires a ten-plus year track record in quality management for medical devices, strong regulatory knowledge, and proficiency

Qualifications

• Bachelor’s degree in quality, or Business Administration, or Scientific field is preferred.
• 10+ years of experience with quality management systems for medical devices.
• Knowledge of regulatory requirements for QMS including 21 CFR Part 820 and ISO 9001:2015.
• Experience with enterprise IT systems from a QMS perspective.
• Experience with 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.

Responsibilities

• Develop and maintain QMS per ISO 9001:2015 and other standards at the SSC level.
• Lead internal quality audits and manage CAPA/NC system.
• Oversee change control, documentation, and OEM liaison.
• Provide QMS training and support for the business unit.
• Assist with audit preparation and execution, records retention, and required reports.
• Support validation activities from a quality systems perspective.

Skills

Quality management

Project management

Regulatory knowledge

Communication skills

Adaptability

Medical devices experience

Education

Bachelor’s degree (quality, business or science)

Tools

SAP

CRM

Agile

SharePoint

Job description

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, CAWhat’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 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.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 Share point 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.The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.This position is eligible for a Performance Bonus.ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.We have amazing benefits to support you as an employee at ZEISS!MedicalVisionDental401k MatchingEmployee Assistance ProgramsVacation and sick payThe list goes on!The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.Your ZEISS Recruiting Team:Jo Anne MittelmanZeiss provides Equal Employment Opportunity without unlawful regard to an Applicants 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).