Quality Engineer 3

Manage and conduct QMS assessments and line audits to evaluate system effectiveness and identify opportunities for improvement, including compliance with Cleanroom protocols, ESD controls, legal requirements, and ISO 9001 standards. Assist in the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry best practices. Prepare, review, and revise QMS procedures, processes, and documentation to support the effective operation and continual improvement of the QMS. Identify improvement opportunities and develop QMS-related training materials for new or revised processes and procedures; provide support during training sessions and awareness programs. Monitor, analyze, and trend assessment and line audit results, and drive continuous improvement initiatives based on data and risk evaluation. Collaborate with cross-functional teams to resolve QMS issues, implement Corrective and Preventive Actions (CAPA), and mitigate quality and compliance risks. Participate in and support internal, external, and customer audits, ensuring readiness, compliance with requirements, and timely closure of findings and observations. Serve as a subject matter expert (SME) on applicable quality standards, regulations, and requirements related to the organization's products, processes, and services. Support other QMS-related activities and initiatives as required to enhance system effectiveness and compliance. Demonstrated experience leading and sustaining a Quality Management System (QMS), with hands‑on execution of ISO 9001:2015 internal and external audits, including process audits and line audits, to evaluate system effectiveness and compliance. Applies strong working knowledge of ISO 9001 requirements, audit methodologies, and compliance expectations to ensure robust and effective quality systems. Proven capability to translate audit findings into effective corrective and preventive actions (CAPA), driving sustainable system improvements. Experience operating in a cleanroom manufacturing environment, with practical understanding of cleanroom discipline, ESD controls, and regulated manufacturing practices. Operates with a high level of ownership and accountability for QMS effectiveness, compliance status, and closure of gaps. Independently drives issues to resolution, ensuring timely and sustainable corrective and preventive actions (CAPA). Focuses on measurable outcomes, using data and audit results to prioritize actions and deliver continuous improvement. Demonstrates strong analytical and problem‑solving capabilities, including root cause analysis and risk‑based thinking. Proactively identifies systemic improvement opportunities and translates them into practical, scalable solutions. Exhibits a continuous improvement mindset, consistently challenging existing processes to improve efficiency, robustness, and compliance. Works effectively across functions and at a global level to achieve quality objectives. Communicates clearly and confidently, influencing teams to adopt QMS requirements and best practices. Minimum of 5 years of relevant professional experience with a bachelor's degree in engineering or equivalent discipline. ISO 9001:2015 Lead Auditor and/or Internal Auditor certified.