Location: Chengdu
Job Responsibilities:
Implement the company's quality policy and various rules and regulations, and assist the management representative in formulating and maintaining the quality system rules and regulations.
Be responsible for the daily supervision and auditing of the regulatory compliance and quality system compliance throughout the entire lifecycle of in-production/in-research products and across all production areas. Timely formulate corrective and preventive measures for existing issues and implement effective rectifications according to the measures plan to ensure continuous improvement and maintain a good operating status of the quality management system.
Assist the management representative in organizing internal and external audits and annual management reviews; prepare annual self-inspection reports for the enterprise as required.
Collect laws, regulations, national standards, and industry standards related to the produced products, interpret and provide training on new regulations. Conduct training and dissemination of laws, regulations, and quality systems for all departments of the quality system to enhance employees' awareness of product quality and compliance.
Be responsible for the verification management of public systems, inspection facilities, and equipment, organizing personnel to complete the verification work according to plans.
Be responsible for the measurement management of the metering verification facilities and equipment across the company, ensuring the completion of metering verifications as planned and verifying the validity of certificates.
Assist superiors in completing other related work.
Requirements for the Position:
Bachelor's degree or above in medicine, laboratory science, biology, immunology, pharmacy, or other related fields that align with the products produced.
A minimum of 3 years of working experience in the same industry, with a thorough understanding of ISO 13485 quality management system, medical device production quality management regulations, appendices related to medical device production quality management such as implantable medical devices, and other relevant laws and regulations.
Experience in on-site internal and external audits, strong sense of responsibility, rigorous and meticulous work attitude, and excellent organizational coordination and communication skills.
Holding an internal auditor certificate.
Resume Submission:
luom@raytecbio.com