Description:

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.

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.

Responsabilities:

• Lead the identification, escalation, and resolution of quality issues, ensuring effective collaboration across Quality, Engineering, and Production teams.
• Drive Nonconformance (NCR) and CAPA investigations, including root cause analysis, risk assessments, and implementation of corrective and preventive actions.
• Ensure proper containment and disposition of non-conforming products, including identification, segregation, and reconciliation.
• Monitor, analyze, and trend quality data to identify risks and improvement opportunities; provide insights and recommendations to management.
• Apply Risk Management tools (e.g., FMEA) to evaluate product and process risks and support decision-making.
• Support and lead validation activities (IQ, OQ, PQ), including process, product, equipment, and software validation.
• Maintain and improve electronic Quality Management Systems (eQMS), ensuring compliance with FDA (including Part 11), ISO 13485, and other applicable regulations.
• Support internal, external, and supplier audits; address audit findings and review engineering changes to ensure product quality and compliance.

Requirements:

• Bachelor’s degree in Engineering.
• Minimum 7 years of experience in Quality Engineering in medical device industry.
• Experience in software validation.
• Strong knowledge of advanced statistics and problem-solving techniques.
• Working knowledge of 21 CFR Part 820 and ISO 13485.
• Advanced English.
• Preferably Six Sigma Black Belt or CQE (ASQ) certification and knowledge of MDSAP requirements.