Account Manager at Maven Workforce
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Director - Quality - Healthcare/Medical Devices (15-25 yrs)
Desired Qualification :
- Minimum 15 yrs of work experience, including at least 10 years in Quality Assurance and Quality Control in manufacturing setup.
- Work experience in multinational company
- Preferable from Medical Devices, IVD or Life Science Healthcare Industry.
- Possess thorough understanding and working experience of ISO 13485, ISO 14971 and ISO 9001 quality system requirements.
Job Description :
- Establishing, implementing and maintaining Quality Management System in by providing leadership of Quality function. (Design, Implementation, Auditing and Continual Improvement):
- Effective communication and engagement with all other departments (including both factory and commercial) to facilitate their engagement and execution of quality-focused, compliant activities.
- Development and maintenance of organizations policy and expertise for quality management systems
- Handling and managing QMS external audits, Notified body Audits, supplier audits
- Quality Assurance of new product development process and design transfer activities meeting required industry and regulatory standard for devices.
- Looking after WHO, cGMP, GxD, ISO etc. guidelines and quality systems. This includes both theoretical knowledge and practical - sleeves rolled up- application of requirements including for example Product complaints, Validations, CAPA- s, labeling controls, Product release activities
Core Competencies :
- Possessing strong leadership qualities with hands-on experience in cooperative application of quality to Operations, Product Development, Logistics, Commercial & Customer Care
- Be a champion for - Quality First- across the organization
- Be a champion for change.
- Strong competencies for depth and breadth of investigation in Root cause analysis
- Identification of Corrective and Preventive actions
- Excellent oral and written communication skills.
- People centric, Flexible
- Organizational, analytical and decision-making skills
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