Senior Quality Assurance Engineer - Medical Devices CAPA Leader

Zeiss Group; Dublin (OH); On-site; USD 116,000 - 145,000; Full time

Benefits offered by this job

Medical plans

Retirement savings plan

Paid time off

Job summary

ZEISS Group in Dublin, CA is seeking a Senior Quality Assurance Engineer to lead quality activities across the product 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 also manages escalated product complaints, coordinates investigations and root-cause analyses, and ensures timely complaint closure while supporting regulatory reporting

Qualifications

• 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.

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.
• 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.

Education

Bachelor's degree in engineering, science, or a related technical discipline

Job description

ZEISS Group in Dublin, CA is seeking a Senior Quality Assurance Engineer to lead quality activities across the product 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 also manages escalated product complaints, coordinates investigations and root-cause analyses, and ensures timely complaint closure while supporting regulatory reporting