Director - Quality - India - Healthcare/Manufacturing/Medical Devices

Designation: Director Quality-India

Location : Manesar

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