Madhu Instruments - Manager - Quality Assurance

1. To act as a Management Representative and fulfil the responsibilities as defined in ISO 13485:2016 standard as given under

- Ensuring that the processes needed for the Quality Management System are documented with the support of Quality System Manual, SOPs, and Records.

- Reporting to the top management on the effectiveness of the Quality Management System and any need for improvement.

- Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

- Planning and conducting the Management Review Meetings (MRM).

- Planning and conducting the Internal Quality Audits.

- Issuing of documents after approval by Top management

- Quality Policy implementation

- Quality Objectives - Establishment and follow ups

2. To act as Person Responsible for Regulatory Compliance and fulfil the responsibilities as given under-

- Establishment & Updating of Technical Files of each product.

- Legal Identification & Updating

- Risk Management activities and ensure compliance with standards and regulations.

- Clinical Evaluation -Establishment and updating.

- PMS - Establishment and updating.

- PMCF - Establishment and updating.

- Liaison with certification & regulatory Bodies

- Liaising with customers and handling the registration documentation matters

- Responsible for IMDR Compliance

- Responsible for EUMDR compliance

- Responsible for EN ISO 13485:2016 implementation

- ISO Audits - Conduct & Follow up of NCRs with Implementation

- CE Audits- Conduct & Follow up of NCRs

- Drugs Audits - Conduct & Follow up of NCRs

- USFDA Audits - Conduct & Follow up of NCRs

- Customer Audits - Conduct & Follow up of NCRs

3. To act as a Manager / Head / In-charge, Quality Assurance and fulfil the responsibilities as given under-

- Develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products are in compliance to the medical device quality standards and requirements

- Coordinate and steer monthly product quality meetings

- Customer Support [Documental and Technical]

- Receipt of customer complaints and resolving the same.

- Implementing customer specified requirement in the plant for production purpose.

- Overall responsible for process control as per defined procedure and need of customers

- Ensuring Training need identification and conducting

- Failure investigation, product complaints and lead corrective and preventive actions

- Assessment of the suppliers.

- Investigation & Disposition of NC product at all stages.

- Validation of Processes, Equipment's and Machines - Plan and Conduct

- Stability Studies

- Batch Production Records Controlling and signing

- Customer Feedbacks - Follow up with sales and Data Analysis

- Annual Product Review