Quality Assurance Manager

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 Senior 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

Requirements:

Work experience should be minimum 15-20 years in medical devices manufacturing.

Excellent computer skills

Goal Oriented

Strong communication skills, including the ability to explain and teach methodologies

Understanding of manufacturing methods and quality standards

A confident and determined approach

Excellent organizational & time management skills

Excellent team handling skills

Qualification:

Diploma/B.E. /B.Sc. degree, masters may be preferred.