Position is with a Japanese MNC in Manufacturing of Medical Devices based out of Chennai Location
Position:: Manager Quality Assurance/QMS
Reporting to: MD [Japanese]
Experience: 4 to 10 years in Quality department with Medical devices manufacturing company.
Location: Medical Devices Park, Chennai
Language: English and Tamil.
- Degree o
rdiploma in engineering (in relevant branch) or in pharmacy or in science in relevant subject and having experience of not less than 2 years in testing of medical devices and more than 3 years of Quality Management experience at medical device manufacturing company. - Knowledge and experience in ISO audits. (Especially ISO9001 and ISO13485)
- Knowledge in ISO13485、CDSCO、Legal meteorology
- Good communication skills and proficient in English, Tamil language, both written and verbal.
- Experience in MS Office (Word and PowerPoint, Excel).
- B. Tech Bachelor of Technology) / diploma holder in Electronic / Electrical / Instrumentation Engineering in a government recognized institute and having an experience of more than 3 years as an engineer in manufacturing factory which has legal metrology licenses.
- Communicate with basic Japanese language
| Key responsibilities/activities | |
| 1. Lead the establishment of Quality Management System (QMS) and its’ process, including the development and revision of policies, facilitating Management Reviews, encouraging participation in QMS promotion committees, and ensuring appropriate quality education and training to ensure that the organization is aligned in its quality objectives and consistently delivers high-quality products. | |
| 2. Oversee the product quality at every stage of its lifecycle, involves gathering and analyzing quality data, making informed quality judgments, approving product shipment based on quality parameters, and holding regular quality meetings, for ensuring consistent quality output, identifying potential issues early, and mitigating risks associated with product quality. | |
| 3. Design, Manage and implement factory operators’ training to ensure that everyone involved in the production process understands and adheres to the organization's quality standards, and that those standards are continually evaluated and improved. | |
| 4. Handle and implement internal and external QMS, Chemical substance Management System(CMS), and other audits to ensure that all operations within the organization meet regulatory standards, industry guidelines, and internal policies. | |
| 5. Manage and implement the inspection and regulatory compliance, includes receiving inspection, outgoing inspection, and investigating the use of regulated substances, to reduce the risk of regulatory non-compliance and ensure that all products are safe, effective, and meet the organization's quality standards. | |
| 6. Manage and handle non-conforming products, involves managing complaints, improving non-conforming parts, issuing Quality Information Sheets (QIS), and validating corrective measures for defective products to ensure that when issues do arise, they are effectively managed and rectified, minimizing potential harm to the customers and the organization. | |