QA / QC Head and PRRC

Company Description

Royal Surgicare Pvt. Ltd. is a trusted manufacturer and exporter of quality medical consumables, based in Santej(Gujarat, India). We offer a wide range of products for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anesthesia, and General surgery. Our facility operates under ISO 13485 : 2016 standards to ensure consistent product quality. We are committed to delivering reliable and precise medical solutions.

Role Description

• Oversee all Quality Assurance and Quality Control activities to ensure product safety, quality, and compliance.
• Ensure adherence to ISO 13485, EUMDR and applicable regulatory requirements.
• Review and approve quality documents, SOPs, and batch records.
• Maintain and update technical documentation and declarations of conformity.
• Ensure product conformity before release and manage regulatory submissions / registrations.
• Monitor post-market surveillance, vigilance, and CAPA activities.
• Lead internal audits, risk management, and training programs.
• Liaise with regulatory authorities, consultants, and Notified Bodies.
• Ensure labeling, traceability, and documentation compliance for all medical devices.
• Support continuous improvement and readiness for inspections and audits.

Qualifications

Skills Required

Iso 13485, Internal Audits, Continuous Improvement, Quality Assurance, Quality Control, Risk Management, Technical Documentation