Senior Quality Engineer

• Lead quality planning activities for new projects, establish product line quality control plans, and develop inspection standards for raw materials, in-process stages, and finished goods.
  
• Perform in-process and final product inspections; compile inspection and batch production records; conduct compliance reviews; and ensure Device History Records (DHR) are complete, accurate, traceable, and properly archived.
  
• Maintain proper product inspection status control and ensure timely and appropriate disposition of non-conforming or held products.
  
• Carry out routine GMP compliance inspections within cleanroom environments and drive adherence to GMP standards in cleanroom operations.
  
• Facilitate cross-functional quality meetings to conduct root cause analysis on issues such as non-conforming products, quality incidents, customer complaints, and adverse events; develop corrective action plans and monitor the closure of NCR and CAPA activities.
  
• Conduct periodic statistical analysis of product line quality performance and recommend continuous improvement initiatives.
  
• Participate in internal quality audits and assist in external audits conducted by customers and regulatory bodies.
  
• Train QC personnel on raw material, in-process, and finished product inspection standards, methodologies, and equipment operation to ensure independent and accurate execution of inspection activities.
  
• Deliver company-wide training on product inspection requirements, process compliance, and overall quality awareness.
  
• Undertake additional responsibilities assigned by the department head and collaborate effectively with cross-functional teams to ensure project objectives are achieved.
  

Requirements

• Bachelor’s degree or above in Chemistry, Biology, Pharmaceutical Sciences, Food Science, Electronics, Mechanical Engineering, or a related discipline, with a minimum of 5 years’ experience in quality control and quality management within medical device manufacturing, particularly involving sterile or metallic implants.
  
• Knowledgeable in cleaning validation, cleanroom control and on-site supervision, preparation of inspection documentation, and batch record review processes.
  
• Well-versed in quality management systems, with ISO 13485 Internal Auditor certification.
  
• Familiar with regulatory standards for sterile medical devices and experienced in operating inspection equipment such as optical measuring instruments and tensile testing machines.
  
• Proficient in new product development workflows and validation processes, with a strong understanding of risk management principles and practices.
  
• Experienced in utilizing quality methodologies and tools, including the Seven QC Tools, Five Core Quality Tools, and Minitab software, to support quality improvement initiatives.
  
• Detail-oriented, accountable, and analytical, with strong logical reasoning and structured problem-solving capabilities.
  
• Demonstrates strong cross-functional collaboration and cross-cultural communication skills, with fluency in English and Mandarin across listening, speaking, reading, and writing.