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Job Description

Job Description : Job Title :

Asst. Manager / Manager

Job Category : Managerial

Department / Group :

Quality Assurance / Compliance

Job Code / Req# : Location :

Davanagere

Reports To

Director

Why does the Position / role exist?

Shah Group of Companies owns multiple subsidiaries focused on the manufacturing and distribution of medical devices. We are growing quickly and seeking a dedicated and detail-oriented Asst. Quality Manager to oversee and manage all aspects of the QMS to ensure compliance with global regulatory standards, including the CDSCO requirements.

The ideal candidate will have a strong background in quality management, familiarity with global regulations, and experience in implementing effective quality systems. This role is crucial in maintaining the integrity of our products and ensuring customer satisfaction through rigorous quality control measures.

Key Responsibilities

• Performs key quality assurance activities in designing and developing products and processes, facilitating design controls and change controls, risk management, quality planning, and implementation of projects and plans.
• Serve as a primary resource and technical subject matter expert in the areas of troubleshooting, problem solving, process / method improvement, and the assurance of quality and compliance of product end-to-end related activities.
• Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, EU MDR, MDSAP, CDSCO, 21 CFR 820, and other applicable standards.
• Conduct validations, investigate customer complaints, and perform supplier audits to ensure compliance with quality standards.
• Lead root cause analysis and corrective action processes for quality issues. Identify trends in quality / compliance to support root cause analysis and CAPA completion.
• Identify and implement quality or compliance improvements with an in-depth analysis of situations and / or data.
• Implement and drive process improvements to enhance product quality and efficiency while ensuring compliance with industry regulations.
• Contribute to developing and implementing quality strategies to support business goals and customer satisfaction.
• Assisting R&D on Design History File requirements from the quality perspective.
• Lead external and internal audits.
• Author, participate in, and / or approve standard operating procedures, forms, test procedures, validation / qualification protocols, summary reports, internal audits, training, technical investigations, and other documents and activities requiring quality assurance / control involvement.
• Authors, revises, and reviews regulated documents and project documents in collaboration with cross-functional teams.
• Ensures all the testing requirements are comprehensive, compliant with standards like ISO 13485, and address all aspects of the device’s lifecycle.
• Along with Regulatory personnel, is responsible for Post-Market Vigilance activities, including complaint handling and root-cause troubleshooting; evaluation and submission of incident or adverse event reports, advisory and product field safety notices, recalls, and reporting.

Educational Background, Knowledge, Skills, and Abilities

Competences :

Reviewed By : Date :

Approved By :

Date :

Last Updated By :

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