Role: QA / QC Manager
Industry Type: Pharmaceutical & Life Sciences
Department: Quality Assurance
Employment Type: Full Time, Permanent
Role Category: Production & Manufacturing
UG: B.Tech / B.E. in Biomedical Engineering, Mechanical Engineering
Company Details: Our client is a Leading Pharma Manufacturer Designation: Quality Assurance Manager Job Location: Sanand, Ahmedabad Role Overview:- We are looking for a person to lead and strengthen its Quality Management System (QMS). The role is responsible for ensuring compliance with ISO 13485, EU MDR, FDA QSR, and other regulatory standards while driving continuous quality improvement across the organization.
Key Responsibilities
Lead and maintain the Quality Management System (QMS) in line with ISO 13485, EU MDR, FDA QSR, and applicable regulatory requirements. Manage quality documentation, SOPs, document control, change control, and Management Review activities. Plan and conduct internal audits while coordinating external, supplier, and regulatory audits. Lead CAPA, non-conformance, deviation, complaint investigations, and root cause analysis. Oversee risk management activities throughout the product lifecycle. Review and approve validation activities, including process, equipment, packaging, sterilization, cleaning, software, and test method validations. Manage supplier quality activities, including supplier qualification, audits, and corrective actions. Ensure effective complaint handling, post-market surveillance, and regulatory compliance. Review Device History Records (DHR) and authorize product release while monitoring product quality trends. Conduct QMS and regulatory training programs to promote a strong quality culture. Support implementation and continuous improvement of electronic Quality Management Systems (eQMS) and digital quality initiatives. Drive continuous improvement initiatives while ensuring regulatory readiness across all departments.
Key Requirements
Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field. Minimum 10 years of experience in the medical device industry, including 5+ years in a Quality Assurance leadership role. Strong expertise in ISO 13485, EU MDR 2017/745, ISO 14971, GMP, CAPA, Risk Management, Process Validation, Supplier Quality, and Internal/External Audits. Hands-on experience with complaint handling, sterilization validation, packaging validation, and regulatory compliance. Internal Auditor Certification (ISO 13485) will be an added advantage. Excellent leadership, analytical, communication, decision-making, and cross-functional collaboration skills. High level of integrity, attention to detail, and a continuous improvement mindset. Contact Person Rishit [email protected] 9723300064