Senior Staff Quality Engineer

Work Flexibility: Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Description: </b></p><p></p><p>As a Senior Staff Quality Engineer, you will play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP.</p><p>This role is critical in maintaining product quality, minimizing risks, and supporting continuous improvement initiatives across manufacturing and engineering processes. You will collaborate cross-functionally to resolve quality issues, enhance processes, and ensure compliance with both internal and external requirements, ultimately safeguarding product integrity and customer trust.</p><p></p><p><b>Responsabilities:</b></p><p></p><ul><li>Lead the identification, escalation, and resolution of quality issues, ensuring effective collaboration across Quality, Engineering, and Production teams.</li><li>Drive Nonconformance (NCR) and CAPA investigations, including root cause analysis, risk assessments, and implementation of corrective and preventive actions.</li><li>Ensure proper containment and disposition of non-conforming products, including identification, segregation, and reconciliation.</li><li>Monitor, analyze, and trend quality data to identify risks and improvement opportunities; provide insights and recommendations to management.</li><li>Apply Risk Management tools (e.g., FMEA) to evaluate product and process risks and support decision-making.</li><li>Support and lead validation activities (IQ, OQ, PQ), including process, product, equipment, and software validation.</li><li>Maintain and improve electronic Quality Management Systems (eQMS), ensuring compliance with FDA (including Part 11), ISO 13485, and other applicable regulations.</li><li>Support internal, external, and supplier audits; address audit findings and review engineering changes to ensure product quality and compliance.</li></ul><p></p><p>Requirements:</p><p></p><ul><li>Bachelor’s degree in Engineering.</li><li>Minimum 7 years of experience in Quality Engineering in medical device industry.</li><li>Experience in software validation.</li><li>Strong knowledge of advanced statistics and problem-solving techniques.</li><li>Working knowledge of 21 CFR Part 820 and ISO 13485.</li><li>Advanced English.</li><li>Preferably Six Sigma Black Belt or CQE (ASQ) certification and knowledge of MDSAP requirements.</li></ul><p></p><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 20%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>