資深品保主管

Job content

• Provide quality engineering support in the manufacturing of medical devices
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Handling with CAPA, deviations, and customer complaints, and drive continuous improvement through analysis of trend data.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards. Establish and maintain quality control procedures, including inspection methods and test protocols.
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
• Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.
  
  

• Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role, with 3 years’ responsibility for Product Quality and/or Quality Systems.
• English working proficiency.
• Ability to communicate ideas and information clearly, effectively, and concisely.
• Working knowledge of Medical Device Regulations: ISO 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
• Familiar with process validation and test method validation.
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Practical knowledge and experience using Minitab or other statistical analysis tools such as Cpk/Ppk analysis, ANOVA and design of experiment.