QA MANAGER Job at Ambattur and Best Salary 70k

1 week ago


Chennai, India green success infotech Full time

QA MANAGER Job at Ambattur and Best Salary 70k Full job description /: Key responsibilities Quality Management System /(QMS/)/: Develop, implement, and maintain an ISO 13485/-compliant QMS, including documentation, procedures, and policies. Stay current with regulatory requirements and industry best practices. Audits/: Lead and manage internal and external quality audits, and support the team during audits by providing necessary records and documentation. Risk Management/: Conduct risk assessments, develop risk mitigation strategies, and participate in risk management activities throughout the product lifecycle. Compliance and Documentation/: Ensure all quality/-related activities and documentation /(e.g., process descriptions, test plans, change controls, deviations/) comply with regulations and internal standards. Review and approve quality records. Problem Solving and Improvement/: Investigate non/-conformities, identify root causes, and implement corrective and preventive actions /(CAPA/). Drive continuous improvement initiatives to enhance product quality and process efficiency. Team and Project Management/: Lead and manage the QA team, provide input and support to cross/- functional teams, and oversee product testing efforts. Product Lifecycle Support/: Provide QA support throughout the design, development, and manufacturing phases to ensure product quality and safety meet specifications and regulatory requirements. Qualifications Bachelors or master's degree in a relevant field like life sciences or engineering. Experience with medical device regulations /(e.g., EU MDR, FDA/) and quality management systems /(ISO 13485/). Strong understanding of quality assurance processes, including CAPA, complaint handling, and internal auditing. Experience in risk management. Excellent analytical, problem/-solving, and communication skills. Experience in managing a QA team. Regards, Nedhra /-HR All the best



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