Sr. Quality Assurance Engineer

How many companies can say they’ve been in business for over 179 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 of 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!

The Senior Quality Assurance Engineer provides quality leadership for assigned product families throughout the product lifecycle. This 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 also manages escalated product complaints, coordinates investigations and root-cause analyses, evaluates potential regulatory reporting obligations, and ensures complete and timely complaint closure.

Location:

Dublin, CA

• 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.
• Support product and process changes by assessing quality, regulatory, and risk-management impacts.
• Lead or support complex quality investigations, root-cause analyses, corrective actions, and effectiveness evaluations.
• Manage escalated product complaints and ensure that 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.

• Bachelor’s degree in engineering, science, or a related technical discipline.
• Minimum 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.
• Experience with medical electronic, ophthalmic, optical, or similar regulated products is preferred.

The annual pay range for this position is $115,900 -…