Sr. Quality Assurance Engineer

ZEISS•Dublin, CA

About The Position

The Senior Quality Assurance Engineer provides quality leadership for assigned product families throughout the product lifecycle. The role partners with Product Management, R&D, Operations, Service, and Purchasing to monitor product and process performance, translate customer and regulatory requirements into quality objectives, and drive risk-based improvements. The position manages escalated product complaints, coordinates investigations and root-cause analyses, evaluates potential regulatory reporting obligations, and ensures complete and timely complaint closure. The position is based in Dublin, California. It provides quality engineering support across manufacturing, purchasing, R&D, and product-sustaining activities, and supports the maintenance and continuous improvement of the Quality Management System. The engineer also leads quality projects, provides technical guidance and training, and supports regulatory inspections and internal or external audits as required.

Requirements

Bachelor’s degree in engineering, science, or a related technical discipline.
At least five years of relevant experience in quality assurance, product development, manufacturing quality, or failure analysis within a regulated industry.
Working knowledge of ISO 13485, FDA Quality Management System Regulation under 21 CFR Part 820, and applicable U.S. and EU medical device requirements.
Experience with complaint investigations, root-cause analysis, CAPA, risk management, and quality-system processes.
Proficiency in statistical methods, including sampling, process capability, confidence intervals, data-distribution assessment, and interpretation of quality data.
Demonstrated ability to lead multiple complex projects and work effectively across functions.
Strong written and verbal communication skills.
Ability to adapt and make sound decisions in a changing environment.

Nice To Haves

Experience with medical electronic, ophthalmic, optical, or similar regulated products.

Responsibilities

Provide quality engineering support for manufacturing, purchasing, R&D, and product-sustaining activities.
Serve as the Quality Assurance representative and subject-matter expert for assigned product families.
Develop and monitor product and process quality metrics, identify adverse trends, and lead appropriate improvement activities.
Apply statistical methods to product acceptance, process capability, sampling, data analysis, and performance evaluation.
Assess quality, regulatory, and risk-management impacts of product and process changes.
Lead or support complex quality investigations, root-cause analyses, corrective actions, and effectiveness evaluations.
Manage escalated product complaints and ensure complaint records are complete, accurate, traceable, and properly maintained.
Assess complaint classification, potential regulatory reporting obligations, and the need for further investigation, risk evaluation, or quality action.
Coordinate complaint investigations, returned-product evaluations, regulatory reporting inputs, stakeholder communication, and timely closure.
Support the maintenance and continuous improvement of the Quality Management System.
Lead quality projects and provide technical guidance and training to other personnel.
Support regulatory inspections and internal or external audits, as required.