QA Engineer

The QA Engineer is responsible for ensuring that all quality assurance activities related to suppliers, materials, Equipment and internal processes comply with applicable regulatory and quality management system requirements. This includes management of nonconforming materials, managing Material Review Board (MRB), responsibility for all calibration and maintenance activities. The role is critical in maintaining compliance with ISO 13485, FDA 21 CFR Part 820, and the company’s Quality Management System (QMS).

Main Responsibilities:

• Coordinate and manage the Material Review Board (MRB) process for nonconforming materials, components, products, and equipment.
• Review and evaluate nonconformance reports (NCRs) to ensure appropriate investigation, risk assessment, and disposition.
• Coordinate with relevant departments, including Manufacturing, Engineering, Supply Chain, and Regulatory Affairs, to determine appropriate material disposition.
• Ensure that MRB decisions are documented, approved, and implemented in accordance with established procedures.
• Monitor MRB activities and ensure timely closure of nonconformances.
• Support root cause analysis and corrective and preventive actions (CAPA) related to nonconforming materials.
• Identify recurring quality issues and drive continuous improvement initiatives.

• Ensure that manufacturing and inspection equipment is maintained, calibrated, and qualified, as applicable, in accordance with approved procedures and regulatory requirements.
• Review and approve equipment maintenance documentation, ensuring that activities are properly documented and traceable.
• Ensure that equipment failures and maintenance-related issues are evaluated for their potential impact on product quality.
• Support investigations related to equipment malfunctions, maintenance failures, and out-of-specification calibration results.
• Ensure that equipment is appropriately released for use following maintenance, repair, calibration, or qualification activities.

• Verify that equipment-related changes are assessed and managed through the change control process.
• Support equipment qualification and validation activities, as applicable.
• Maintain accurate and complete quality records related to MRB, equipment, and maintenance activities.
• Identify quality system gaps and implement corrective actions to improve compliance and operational effectiveness.
• Collaborate with cross-functional teams to promote quality awareness and a culture of continuous improvement.
• Support in complaint handling process.
• Support system release and incoming inspection when needed.