What are the responsibilities and job description for the Quality Enginee position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
CAPA (Corrective and Preventive Actions) Management:
CAPA (Corrective and Preventive Actions) Management:
- Initiate, investigate, and lead CAPAs to address identified non-conformities.
- Conduct root cause analysis and implement long-term corrective measures.
- Track and monitor the effectiveness of CAPA implementations, ensuring timely completion and documentation.
- Analyze, update, and optimize the existing quality management system (QMS) to ensure compliance with regulatory requirements and industry standards.
- Implement corrective actions to bring quality system elements into compliance, including document control, design controls, risk management, and production controls.
- Collaborate with cross-functional teams, including manufacturing, design, and operations, to achieve and maintain quality objectives.
- Oversee and improve post-market surveillance activities, including monitoring adverse events, complaints, and product recalls.
- Analyze post-market data to identify trends and potential quality issues, developing corrective actions as necessary.
- Ensure compliance with FDA and international regulatory requirements in post-market surveillance activities and feed data back into the quality system for continuous improvement.
- Lead risk management activities in accordance with ISO 14971, ensuring adequate identification, assessment, control, and mitigation of product and process risks.
- Integrate risk management activities with other quality system elements, including design controls, process validation, and post-market surveillance.
- Develop, implement, and validate robust processes to improve process quality and reduce variability, enhancing product reliability.
- Partner with manufacturing and operations teams to ensure production processes meet established quality standards and regulatory compliance.
- Conduct, document, and maintain process validation activities (IQ/OQ/PQ) and ensure proper validation and control of any process changes.
- Collaborate with R&D and design engineering teams to ensure quality is integrated throughout the product development lifecycle, from concept to commercialization.
- Support the development and validation of design inputs, outputs, design verification, and validation activities in accordance with FDA and ISO requirements.
- Ensure proper documentation of design control elements, facilitating traceability, risk management, and compliance.
