Senior Quality Assurance Specialist

Overview

Senior Quality Assurance Specialist responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, international standards, and company procedures, supporting quality operations across distribution, supplier management, post-market surveillance, and quality system processes.

What you'll do

• Maintain and continuously improve the Quality Management System in accordance with applicable regulations and standards.
• Ensure compliance with ISO 13485, MDR, and other applicable regional requirements.
• Lead investigations related to non-conformances, deviations, complaints, and quality issues.
• Facilitate root cause analysis using appropriate quality tools.
• Manage Corrective and Preventive Action (CAPA) activities from initiation through effectiveness verification.
• Plan, coordinate, and participate in internal audits.
• Support external audits by certification bodies, notified bodies, regulatory agencies, and customers.
• Support supplier qualification, evaluation, and monitoring activities.
• Participate in supplier audits and quality reviews.
• Manage supplier-related quality issues and corrective actions.
• Review and assess proposed changes for quality and regulatory impact.
• Ensure appropriate risk assessments and approvals are completed for changes.
• Monitor change implementation and effectiveness.
• Participate in risk management activities throughout the product lifecycle.
• Support risk assessments associated with processes, suppliers, products, and quality events.
• Ensure quality risks are identified, documented, and mitigated.
• Provide guidance to employees on quality system requirements.
• Support compliance training and awareness programs.
• Promote a culture of quality and continuous improvement throughout the organization.
• Develop and monitor key quality performance indicators.
• Analyse quality trends and identify opportunities for improvement.
• Lead or participate in continuous improvement initiatives.
• Present quality performance data to management.
• Support health authority inspections and certification audits.
• Assist in preparation of audit responses and quality records.
• Ensure ongoing inspection readiness across the business.

What you'll need

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related discipline.
• 5-7 years of Quality Assurance experience in a regulated industry.
• Minimum 2-3 years working within the Medical Devices Industry.
• Experience working with Quality Management Systems compliant with ISO 13485.
• Strong influencing skills.
• Excellent verbal and written communication.
• Strong stakeholder management.
• Critical thinking and problem-solving.
• Ability to manage multiple priorities in a fast-paced environment.

Nice to have

• Master's degree in a relevant scientific or technical field.
• ASQ Certified Quality Auditor (CQA) or equivalent certification.

Details

• Location: Hyderabad, Telangana, India.