Senior QA Engineer, Medical Devices & CAPA Lead

Carl Zeiss SMT; Dublin (CA); Vor Ort; USD 116.000 - 145.000; Vollzeit

Benefits dieser Stelle

Performance bonus

Medical plans

401k matching

Paid time off

Employee assistance programs

Zusammenfassung

ZEISS in Dublin, CA, is seeking a Senior Quality Assurance Engineer to lead quality initiatives across product families and lifecycle. You will partner with PM, R&D, Operations, Service, and Purchasing to transform customer and regulatory requirements into robust quality objectives and drive risk-based improvements.

You will manage escalated complaints, coordinate investigations and root-cause analyses, and ensure timely closure while supporting regulatory reporting obligations and internal

Qualifikationen

• Bachelor's degree in engineering, science, or related 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 QMS 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.

Aufgaben

• Provide quality engineering leadership for assigned product families throughout the lifecycle.
• Serve as QA representative and SME for assigned product families.
• Develop and monitor product and process quality metrics; identify adverse trends and lead improvements.
• Apply statistical methods to acceptance, capability, sampling, data analysis, and performance evaluation.
• Support changes by assessing quality, regulatory, and risk-management impacts.
• Lead complex quality investigations, root-cause analyses, CAPA, and effectiveness evaluations.
• Coordinate complaint investigations and regulatory reporting inputs; ensure timely closure.
• Contribute to ongoing maintenance and improvement of the Quality Management System.
• Lead quality projects and provide guidance and training across teams.
• Support regulatory inspections and audits as required.

Kenntnisse

Statistical methods

Cross-functional collaboration

Communication skills

Decision making

Ausbildung

Bachelor's degree in engineering or related field

Tools

CAPA system

Quality Management Software

Jobbeschreibung

ZEISS in Dublin, CA, is seeking a Senior Quality Assurance Engineer to lead quality initiatives across product families and lifecycle. You will partner with PM, R&D, Operations, Service, and Purchasing to transform customer and regulatory requirements into robust quality objectives and drive risk-based improvements.

You will manage escalated complaints, coordinate investigations and root-cause analyses, and ensure timely closure while supporting regulatory reporting obligations and internal