Quality Manager

Job Description

Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, IEC 62304, and ISO 27001 standards. Oversee all quality control activities, ensuring compliance with regulatory requirements and internal standards. Lead and foster a culture of quality excellence. Conduct internal and external audits, identifying and mitigating risks to product quality and patient safety. Collaborate with cross-functional teams to drive continuous improvement initiatives. Manage and reduce quality-related costs while maintaining high-quality standards. Conduct risk assessments and implement risk mitigation strategies. Ensure effective management of non-conformances and corrective actions. Independently lead certification and re-certification audits to maintain compliance with necessary quality standards. Stay abreast of quality standards and industry best practices. Qualifications: Bachelors degree in a relevant field (e.g., engineering, science, quality management). Minimum of 5 years of experience in a quality management role within the medical device or healthcare industry. In-depth knowledge and practical application of ISO 13485, IEC 62304, and ISO 27001 standards. Proven experience in leading and managing quality teams. Strong analytical, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Experience in conducting audits and inspections. Proven experience in independently leading certification and re-certification audits. Proficiency in quality management software and tools. Benefits: Competitive salary and benefits package Opportunity to contribute to the development of innovative healthcare solutions Collaborative and supportive work environment Professional growth and development opportunities