QA Manager – Medical Devices Work location: Obour & Ismailia
Business Leaders is hiring on behalf of one of our clients, a well-established company operating in the medical devices manufacturing sector, for a senior QA Manager to lead Quality Assurance and Compliance across two manufacturing facilities in Obour and Ismailia.
???? The Role The QA Manager will be responsible for establishing, maintaining, and continuously improving the Group Quality Management System, ensuring that both manufacturing sites operate in compliance with applicable quality and regulatory requirements for medical devices. The role requires a strong QA professional who can combine hands-on quality management with regulatory and compliance leadership.
???? Key Responsibilities Lead and oversee QA & Compliance activities across both manufacturing sites. Develop, maintain, and improve the Quality Management System (QMS). Ensure compliance with applicable medical device quality and regulatory requirements. Establish and maintain quality procedures, SOPs, forms, records, and document-control systems. Manage deviations, CAPA, change control, non-conformities, and root-cause investigations. Lead internal and external audits and regulatory inspections, including preparation and follow-up of corrective actions. Ensure effective implementation of quality requirements throughout production, packaging, warehousing, and related operations. Monitor quality performance through appropriate QA KPIs and quality indicators. Work closely with Production, QC, Supply Chain, Maintenance, and Management to resolve quality issues and improve processes. Ensure appropriate training and competency related to quality procedures and regulatory requirements. Support regulatory and technical documentation requirements related to products and manufacturing activities. Drive a culture of quality, compliance, continuous improvement, and risk-based thinking across both facilities.
???? Candidate Requirements Must Have:Bachelor's degree in Pharmacy, Science or a relevant scientific/technical discipline.12+ years of professional experience in Quality Assurance, preferably within regulated manufacturing environments. At least 3 years of direct experience in the medical devices industry. Strong experience in QMS implementation and management. Solid practical experience in CAPA, Change Control, Deviations, Risk Management, Internal Audits, and Document Control. Experience working closely with manufacturing and production teams. Strong leadership and cross-functional management capabilities. Ability to manage QA operations across multiple manufacturing locations. Preferred:Experience in IVD (In Vitro Diagnostic) manufacturing. Experience with CE Marking requirements and European medical-device regulatory requirements. Experience with ISO 13485 and medical-device quality management systems. Experience with regulatory inspections and third-party certification audits. Exposure to MDR / IVDR requirements would be an advantage. Interested candidates are invited to apply through Linked In or send CV to [[Click to show email]] with the subject line “QA Manager”