Medical Devices Quality Assurance Manager

Overview

Quality Assurance Professional

We are seeking a seasoned quality assurance professional to join our team.

Job Description :

The selected candidate will be responsible for managing our Quality Management system for medical devices, ensuring compliance with regulatory requirements such as MDR / IVDR, ISO 13485, and MDSAP. This includes overseeing external audits, internal audits, and communication with relevant departments. Additionally, the successful candidate will be responsible for maintaining designation under MDR / IVDR and supporting the development and designation under new schemes.

This role requires strong knowledge of medical device regulations, excellent interpersonal and communication skills, and the ability to represent our organization to regulatory authorities and other external forums.

Responsibilities

• Develop and implement quality management systems (QMS) aligned with global processes and accreditation requirements.
• Ensure QMS regulatory compliance to support designation and accreditation under MDR / IVDR, ISO 13485, MDSAP, and other relevant schemes.
• Lead internal and external audits and ensure timely closure of corrective actions.
• Analyse data for management review reporting and make informed decisions to drive continuous improvement.
• Manage all regulatory processes to ensure full compliance across all medical schemes.

Skills & Qualifications

Essential

Qualifications :

Benefits

This is a unique opportunity to join a leading organisation and contribute to the development of innovative solutions.

How to apply

Please submit your CV in English for consideration.

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