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Quality Complaints Specialist

2 months ago

Hyderabad, India Tek Support Full time
Position Overview :We are seeking an experienced

Quality Complaints Specialist

to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and implement corrective actions. The ideal candidate will also provide insights for continuous improvement and ensure timely communication with regulatory bodies and customers.

Key Responsibilities :Complaint Management : Oversee the intake, documentation, and processing of product complaints, ensuring they are logged and addressed in a timely manner.Root Cause Investigations : Lead detailed investigations to identify the root cause of product complaints, collaborating with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams.Risk Assessment & Escalation : Evaluate complaints to determine risk and severity, escalating high-risk issues as needed to ensure swift resolution.Documentation & Reporting : Maintain accurate and detailed records of all complaint investigations, ensuring compliance with regulatory standards and internal procedures.Regulatory Compliance : Ensure compliant and timely reporting of adverse events to regulatory bodies, including CDSCO, US FDA, and EU MDR, in line with regulatory guidelines.Trend Analysis : Analyze complaint data to identify trends and potential product quality issues, generating reports and presenting findings to leadership.Continuous Improvement : Participate in initiatives aimed at improving the complaint handling process, providing valuable feedback to product design and manufacturing teams.Customer Communication : Serve as a point of contact for customers regarding product complaints, providing timely updates and resolutions.

Required Qualifications :Experience : 3-5 years of experience in a quality complaints role, ideally within the medical device industry.Technical Skills :Proficiency in complaint management systems and root cause analysis.Strong knowledge of regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.Hands-on experience with Corrective and Preventive Action (CAPA) processes.Analytical Skills : Ability to analyze data and identify trends to inform product improvement efforts.Communication Skills : Strong verbal and written communication skills for interaction with customers, internal teams, and regulatory authorities.

Preferred Skills :Experience working with regulatory bodies and knowledge of global medical device regulations.Familiarity with complaint handling best practices and continuous improvement methodologies.