Sterilization Engineer Medical Device

• Manage sterilization service providers to ensure they are complying with the latest regulatory requirements and current governed standards.
  
• Supervise and support the internal sterilization process to ensure the latest regulatory requirements and current governed standards are adhered to.
  
• Manage the sterilization validation process including preparing and reviewing of protocol & report.
  
• Supervision and organization of the environmental control to ensure the cleanroom / controlled room is working within specification.
  
• Supervision and organization of the hygiene practices and microbiological control to ensure the practice is conform to requirement.
  
• Supervise the investigation and action for the anomaly of the microbiological issues.
  
• Supervise and manage the outsourced testing laboratory to ensure the test method is comply to requirement.
  
• Leading/supporting nonconformance investigation activities derived from internal/external including risk assessment root cause analysis implementing corrective & preventive action etc.
  
• Identify and initiate improvement activities through analysis of data from quality records.
  
• Ensure the periodic validation review is conducted in a timely manner.
  
• Support in internal and external audit process.
  
• Execute supplier audit including generating audit plan preparing audit report follow up with supplier reply etc.
  
• Work with Supply Chain to ensure the Supplier Corrective Action Report issued to supplier is closed in a timely manner.
  
• Assist and report all microbiological and sterilization related matters to superior.
  

Requirements

• Candidate must possess at least Degree in Microbiology or sciencerelated field or equivalent
  
• At least 2 years working experience in handing microbiological related tasks & sterilization process in a manufacturing industry preferably in the Medical Device industry.
  
• Preferably candidate with good knowledge of ISO 13485 GMP and FDA 21 CFR Part
  
• Have similar experience working in cleanroom environment.
  
• Able to work in a team and under minimum supervision.
  
• Strong interpersonal analytical and problemsolving skills.
  
• Initiative proactive resourceful able to multitasks and work independently.
  
• Good written and verbal communication skills in English and Bahasa Melayu
  
• Computer literate