Senior QA Engineer - Medical Devices

Carl Zeiss Meditec, Inc.; Dublin (CA); On-site; USD 116,000 - 145,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS seeks a Senior Quality Assurance Engineer to provide quality leadership for product families throughout their lifecycle. You will partner with Product Management, R&D, Operations, Service and Purchasing to translate customer and regulatory requirements into quality objectives and drive risk-based improvements.

The role includes managing escalated complaints, coordinating investigations and root-cause analyses, evaluating regulatory obligations, and ensuring timely closure while

Qualifications

• Bachelor’s degree in engineering, science, or a related technical discipline.

Responsibilities

• Provide quality engineering support for manufacturing, purchasing, R&D, and product-sustaining activities.

Skills

Quality assurance

Complaint investigations

Root-cause analysis

CAPA

Risk management

Quality-system processes

ISO 13485 knowledge

FDA QMS (21 CFR 820) knowledge

Statistical methods

Cross-functional collaboration

Education

Bachelor’s degree in engineering/science

Job description

ZEISS seeks a Senior Quality Assurance Engineer to provide quality leadership for product families throughout their lifecycle. You will partner with Product Management, R&D, Operations, Service and Purchasing to translate customer and regulatory requirements into quality objectives and drive risk-based improvements.

The role includes managing escalated complaints, coordinating investigations and root-cause analyses, evaluating regulatory obligations, and ensuring timely closure while