QC Manager

• Manage the quality management system at the medical device manufacturing plant, ensuring compliance with ISO 13485, GMP, and relevant regulatory standards.

• Establish, maintain, and continuously improve quality documentation systems and quality control processes for incoming materials, in-process, and finished products.

• Collaborate with cross-functional teams to handle quality issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).

• Participate in internal audits and external audits from customers, partners, and regulatory bodies.

• Train and develop the quality team to ensure high performance and compliance.

• Work directly with customers and suppliers to ensure quality requirements are met.

• Prepare and present regular quality performance reports and improvement proposals.

• Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, or related fields.

• Minimum 5 years of experience in quality management, preferably in the medical device industry.

• Prior experience at companies such as B. Braun, Terumo, or other foreign-invested medical device manufacturers is highly preferred.

• Proficient in English (mandatory); Chinese language skills are a strong plus.

• Solid knowledge of ISO 13485, ISO 9001, GMP, and FDA 21 CFR Part 820 standards.

• Strong leadership, communication, and problem-solving skills.

Manpower