Qa Executive

Job Description

Job Summary The QA Executive will be responsible for ensuring the quality and compliance of In Vitro Diagnostic (IVD) products throughout their lifecycle. This role involves monitoring, inspecting, and enforcing compliance with regulatory standards, quality management systems (QMS), and Good Manufacturing Practices (GMP) to ensure the production of high-quality, safe, and effective diagnostic products. Key Responsibilities: Quality Management System (QMS) : Implement and maintain QMS in accordance with regulatory requirements, including ISO 13485:2016, and other relevant standards such as CE and FDA (if applicable). Regulatory Compliance : Ensure the company's IVD products comply with Indian regulations (such as CDSCO) and international standards (if applicable). Keep updated on evolving regulatory guidelines and ensure timely compliance. Documentation : Oversee the creation and maintenance of necessary quality documents, including SOPs (Standard Operating Procedures), quality manuals, batch records, and validation protocols. Product Quality Control : Conduct internal audits, inspections, and reviews of product quality. Ensure proper testing, inspection, and validation of products to meet established quality standards. Root Cause Analysis & CAPA : Investigate non-conformities, customer complaints, and quality issues. Develop and implement corrective and preventive actions (CAPA) to ensure the elimination of recurring issues. Validation & Verification : Review validation and verification protocols, including process validation, equipment qualification, and product testing. Ensure proper documentation and implementation of all validation activities. Training & Support : Conduct training on quality procedures, standards, and regulatory requirements for production staff and other relevant departments. Supplier Quality Management : Ensure that materials and components from suppliers meet quality standards by conducting supplier audits and evaluations. Inspection & Testing : Oversee incoming raw material inspection, in-process testing, and final product quality checks to ensure compliance with specifications. Compliance Reporting : Assist in preparing and submitting compliance-related reports, including internal and external audits, regulatory inspections, and product registrations. Qualifications: Educational Requirements : Bachelors or Master’s degree in Life Sciences, Biotechnology, Microbiology, Pharmacy, or a related field. Experience : Minimum of 2–3 years of experience in Quality Assurance in an IVD or medical device manufacturing environment. Familiarity with IVD regulatory requirements (CDSCO, ISO 13485:2016, etc.) and quality standards. Knowledge : Strong understanding of IVD product life cycle, quality standards, and regulatory compliance. Experience with ISO 13485:2016, GMP, and relevant IVD regulations. Technical Skills : Knowledge of validation processes, CAPA systems, and quality control testing methods. Proficiency in using QMS software and MS Office Suite. Preferred Skills: Familiarity with ISO 14971 (Risk Management for Medical Devices) and IEC 62304 (Software Life Cycle Processes for Medical Devices). Prior experience in supplier quality management or product registration in India. Ability to conduct internal audits and lead quality improvement initiatives. Strong analytical skills and attention to detail. Excellent communication and teamwork skills.