Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.
Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.
Roles & Responsibilities – Quality Assurance Engineer/Sr. Engineer
– Excellent experience in medical device Quality Management System, Quality assurance, production activities.
– Must have knowledge and experience of working as per the requirements of ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, and applicable regulatory requirements.
– Must have experience with managing requirements for different QMS elements like Management Controls, Training requirements, Internal & external Audits, Document Control, Change Management, Manufacturing Controls / Records, Quality Instructions / Records, Supplier Management, Complaints / Reporting, CAPA, NCRs.
– Must have experience in supporting other QMs areas as needed, including but not limited to internal and external audit support; training development and management; NCRs/CAPA investigations, corrective actions, and effectiveness checks.
– Knowledge of DMR (Device Master Records), DHF (Design History File) & DHR (Device History Records)
– Implement and manage a robust risk management system in accordance with ISO 14971 to identify, assess, and mitigate product and process risk.
– Address audit findings and corrective and preventive actions (CAPA) as needed.
– Supports during regulatory inspections, audits, and Management Reviews.
– Experience in exercising appropriate controls on the process & product to ensure compliance.
– Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
– Report and evaluates repetitive complaints and product evaluation results for negative trends.
– Coordinate development and change control activities product quality plans, inspection forms (Incoming, in-process, and final QC), methods of manufacturing, item master, inspection rules, and other documents as needed.
– Experience with quality management tools and techniques.
– Experience with change management methodology, coordinate and manage change management activities.
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Qualification –
Bachelor’s degree in a technical discipline (Mechanical engineering/Bio Medical/Biotechnology)
should have minimum 5 to 7 years of experience in quality management, preferably in a medical device manufacturing environment.
– Communicate across all supporting cross-functions and key stakeholders.
– Excellent communication skills, oral, written, and electronic
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