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Touracle India Pvt Ltd; Kuala Lumpur; On-site; MYR 120,000 - 160,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking an Asst. Quality Manager to ensure compliance with global regulatory standards. The ideal candidate will have over 10 years of experience in quality management and a strong background in regulatory compliance. Responsibilities include overseeing the QMS, conducting validations, and leading audits. This role requires excellent communication and interpersonal skills, along with a willingness to travel. The company offers a dynamic work environment with opportunities for professional growth.

Qualifications

• 10+ years of related experience in QA/RA in a medical device manufacturing environment.
• Experience and/or understanding of Class II and Class III medical devices.
• Knowledge of inspection and audit processes.

Responsibilities

• Oversee and manage all aspects of the QMS to ensure compliance with global standards.
• Conduct validations, investigate customer complaints, and perform supplier audits.
• Lead root cause analysis and corrective action processes for quality issues.

Skills

Quality management

Regulatory compliance

Risk management

Interpersonal skills

Communication skills

Education

Bachelor's or master’s in science or engineering

Tools

ISO 13485

FDA regulations

Job description

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

• Bachelor's or master’s in science or engineering.
• 10+ years of related experience in QA/RA in a medical device manufacturing environment.
• Knowledge of the FDA medical device regulations & ISO 13485 Quality Management Standard, EU MDR, and CDSCO.
• Experience and/or understanding of Class II and Class III medical devices.
• Knowledge of reliability, maintainability, and risk management, including key terms and definitions, systems design, assessment tools, and reporting.
• Technical knowledge of medical device verification and validation.
• Understanding of FDA QSR Part 820, ISO 13485, ISO 14971, EU MDD / EU MDR, CDSCO.
• Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Knowledge of inspection and audit processes, including types of audits, planning, preparation, execution, reporting results, and follow-up.

Competences

• Excellent communication and time management skills
• Strong interpersonal and leadership skills; you will be working with all employees.
• Attention to detail and excellent organizational skills.
• Must be hands-on and willing to perform a variety of roles and functions.
• Willing to travel domestic and international as required.