Lead/Senior QA Engineer, Quality Management System (Qms)

Role Overview: The Lead / Senior QA Engineer (QMS) is responsible for maintaining and improving company’s Quality Management System to ensure compliance with ISO 13485, EU MDR , MDSAP, and evolving FDA requirements under the new QMSR (21 CFR Part 820). This role will be responsible for key quality system processes including document and record control, non-conformance and CAPA management, including supplier quality resolution and supplier quality audit accordance with ISO 13485 compliance. QMS engineer is responsible for the lead auditor role and ensuring internal and external audit readiness. Key Responsibilities: 1. Quality Management System Oversight Maintain and continuously improve the company’s QMS to ensure compliance with applicable standards and regulations. Ensure QMS processes are effectively implemented across cross-functional teams. Support organization-wide adherence to document control and record retention policies. 2. Document & Record Control Oversee QMS documentation, including Quality Manual, Procedures, SOPs, WI, and forms/templates. Ensure controlled documentation is current, accessible, and aligned with regulatory expectations. Maintain QMS repositories (e.g electronic QMS platform). 3. Audit & Inspection Readiness Plan, coordinate, and support internal, external, supplier and regulatory audits. Ensure audit findings are appropriately documented, addressed, and closed in a timely manner. Act as key contributor during regulatory inspections and third-party assessments. 4. CAPA, Nonconformance & Continuous Improvement Lead management of internal and external nonconformances related to product and process. Drive robust CAPA investigations using structured problem-solving methodologies. Monitor effectiveness of corrective and preventive actions to ensure sustainable improvements. 5. Supplier and Component Quality Support Support qualification of critical components in accordance with defined requirements. Manage supplier’s nonconformance including containment and follow-up actions. Track supplier quality issues and escalating risks as needed. Supplier/Contract manufacturer quality support for NPI (New Product Introduction) projects. 6. Change Management & Quality Records Support design and process change control activities, ensure changes are properly evaluated, tracked and approved. Ensure training is planned, conducted, and completed for all QMS changes, and that training effectiveness is appropriately documented. Maintain key quality records such as Medical Device File and Medical Device Batch Records and related controlled documents. 7. Risk Management (ISO14971) Own and maintain Risk Management Files in accordance with ISO14971. Ensure risk assessment remains current throughout product lifecycle and post-market activities. Competency Requirements: Bachelor Degree of Engineering or equivalent or higher. Minimum 8–10 years of Quality Assurance experience, with strong focus on QMS and compliance. At least 5 years working within the medical device industry or other regulated environments. Hands-on experience supporting compliance to: - ISO 13485:2016 - EU MDR - MDSAP - FDA QMSR (21 CFR Part 820) Certified ISO 13485:2016 Internal Auditor/Lead Auditor. Strong knowledge of medical device risk management(ISO14971). Strong analytical and problem-solving skills. Effective communicator and collaborative partner across functions. Able to work independently in a fast-paced, dynamic medtech environment. Proficiency in MS Office and document management systems (SharePoint/eQMS).