Assistant Manager / Manager - Quality Assurance

Position Overview The Assistant Manager / Manager – Quality Assurance will be responsible for establishing, maintaining, and continually improving the Quality Management System (QMS) in compliance with ISO 13485:2016, EU IVDR, MDSAP, and Indian Medical Device Rules 2017 across the full lifecycle of IVD products. This role will provide QA oversight across manufacturing and post-market activities, ensure regulatory compliance, drive continuous improvement initiatives, and foster a strong quality culture. The incumbent will report to the Head of QA and work closely with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Sales teams. Key Responsibilities Oversee document and record control, deviations, change control, incidents, OOS, and quality risk management processes. Manage Nonconformance and CAPA processes: lead root cause analysis, ensure implementation of effective corrective/preventive actions, and report CAPA trends to QA Head. Plan, monitor, and support internal and external audits; confidently manage regulatory inspections. Identify, design, and implement training programs for QA and cross-functional teams to promote a culture of quality and compliance. Drive continuous improvement through proactive risk management and cross-functional collaboration. Skills & Attributes Strong understanding of IVD / Molecular Biology products. In-depth knowledge of ISO 13485:2016 and ISO 14971 (Risk Management). Proven ability to lead audits and regulatory inspections successfully. Strong leadership, interpersonal, and team management skills. Excellent collaboration and stakeholder management abilities. Proactive and solution-oriented mindset, with a strong focus on quality culture. High attention to detail and risk-based thinking. Communication Skills Strong verbal and written communication skills. Ability to simplify and effectively communicate complex regulatory/quality requirements to diverse stakeholders. Behavioral Attributes High integrity and professionalism. Strong analytical and problem-solving abilities. Customer-focused and committed to compliance excellence. Demonstrates a continuous improvement mindset. Highly adaptable to a dynamic regulatory environment. Experience 12 to 15 years of experience in the IVD industry, with at least 3 to 5 years in a leadership/managerial role.

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