quality manager, sterilization.

Quality Manager, Sterilization

Core Job Responsibilities

• Manage new suppliers and products development process that related to sterility assurance in Asia by doing below:
  • Supplier audit against related standards (CFR820, ISO13485, ISO11135, ISO11137.)
  • ETO sterilization validation
  • Steam sterilization validation
  • Irradiation validation
  • Packaging validation
• Manage existing suppliers and products sterility assurance related activities in Asia by doing below:
  • Sterilization revalidation
  • Routine sterilization audit
  • CAPA, SCAR
• Collaborate and interact with cross-functional teams within Medline. Provide technical supports, suggestions, training as needed. Align with key stakeholders to enable goal attainment.
• Seek opportunities for continuous improvement of processes and techniques. Able to get resources to implement the plan. Update procedures as needed to maintain compliance and improvement.
• Build the competent team by making and implementing clear team development plans with comprehensively considering Medline GSO needs and resources.
  • Develop and coach the team though on-boarding, training, performance management and development opportunities.
  • Provide appropriate feedback and direction in time.
  • Seek team members’ insights and work collaboratively towards goals with individual perspectives integrated.
  • Support initiatives to build and maintain team engagement and positive employee morale.
• Other work assigned by Leader or manager.

Basic Technical Skills

• • Able to solve quality issues with systematic problem-solving skills.
  • Good communication skills, able to work under pressure.
  • Proactive, Responsible, Flexible, Positive & Continuous.
  • Willing to travel, travel rate is about 30-50%.

skills and experience required.

Job Requirement

• Education level: Bachelor or above, major with science or engineering background.
• Working experience: Minimum 3 years working experience in related area and have management experience. Experience in medical device is an advantage.
• Specific knowledge: Biological and chemical background is preferred.
• Certifications: ISO13485, CFR820 is preferred.
• Language: Fluent at both verbal and written English.