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.