QA/QC Head and PRRC

4 days ago

Gandhinagar, Gujarat, India Royal Surgicare Pvt. Ltd. Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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

  • Quality Control and Quality Assurance skills
  • Quality Management and Analytical Skills
  • Laboratory Skills
  • Excellent written and verbal communication skills
  • Strong interpersonal and leadership abilities
  • Familiarity with ISO and EUMDR standards

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