Quality Systems Engineer - Change & Compliance

ZEISS Group; Dublin (CA); On-site; USD 84,000 - 104,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS in Dublin, CA seeks a Quality Assurance professional to support QA across operations, ensuring ISO 9001 QMS and ISO 14001 EMS compliance while improving process performance.

You will oversee change management, audits, CAPA, and supplier/customer investigations, collaborating with cross-functional teams and contributing to ERP initiatives. On-site role with domestic/international travel required.

Qualifications

• Mechanical, Electrical, or Mechatronics Engineering degree required.
• Strong computer skills with MS Office (Excel, Outlook).
• Ability to evaluate drawings and technical documents.
• Experience with ISO 9001 QMS and ISO 14001 EMS preferred.
• Proficient in SolidWorks to evaluate 2D/3D CAD files preferred.
• Ability to lead investigations using CAPA methodologies (e.g., 8D).
• Excellent written and spoken communication; teamwork.
• On-site position with willingness to travel.

Responsibilities

• Oversee daily Change Management operations (ECR/ECO/DCO/PCO).
• Oversee Change Management process operations and approvals.
• Evaluate engineering and process documents for modifications.
• Maintain revision-controlled documents and distribution.
• Update ISO 9001 QMS and ISO 14001 EMS records.
• Audit quality logs and storage for compliance.
• Support CAPA, CAR, and SCAR processes.
• Participate in QMS and ERP-related initiatives.
• Develop KPIs for document control processes.
• Manage item master and BOMs in the MRP database.
• Assist in new product introduction documentation.
• Support inquiries from customers/suppliers; investigations.
• Lead continuous improvement aligned with business priorities.

Skills

Change Management

Document Control

Quality Assurance

CAPA / 8D

Audits

Cross-functional collaboration

MS Office (Excel)

SolidWorks

Technical drawing evaluation

Problem Solving

Education

Mechanical, Electrical or Mechatronics Engineering degree

Tools

SolidWorks

Job description

ZEISS in Dublin, CA seeks a Quality Assurance professional to support QA across operations, ensuring ISO 9001 QMS and ISO 14001 EMS compliance while improving process performance.

You will oversee change management, audits, CAPA, and supplier/customer investigations, collaborating with cross-functional teams and contributing to ERP initiatives. On-site role with domestic/international travel required.