Quality Engineer – Sterilization

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Description

Quasar, a global B2B medical device manufacturer is looking to hire a Quality Engineer – Sterilization who will join our Quality Department at Singapore.  This position will report to Quality Manager

The ideal candidate is expected to provide expertise related to microbial control/test, sterilization, and disinfection/cleaning, to ensure compliance with Quasar’s standards, appropriate industry and government regulations/standards and customer’s requirements.

Responsibilities
  • Establish sterile processes and microbial control/monitoring/management procedures
  • Develop procedures/WIs for microbial sampling and testing, develop test methods & validation protocols with the contract lab
  • Lead the identification and selection of appropriate sterilization method/technology and management of sterilization validation efforts
  • Communicate with outsourcing supplier/contract service as technical contact person for sterilization
  • Mentor other junior personnel in microbial control and sterilization concept.
  • Conduct supplier audits and support regulatory or customer audits.
  • Other tasks relating to microbial control, cleanroom environment/process, sterilization, disinfection/cleaning process, monitoring and control of purified water system.
  • Maintain and comply with the requirements of IS013485, GMP, FDA 21 CFR Part 820 and other applicable regulations.
  • To support audits from customers and external regulatory agencies (FDA, BSI etc)
  • Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle
  • Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.
  • Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions.
Requirements
  • Bachelor’s degree in science discipline, such as Microbiology, Biomedical engineering or related Science or engineering discipline
  • More than 3 years’ experience in healthcare product development and/or manufacturing process,
  • Solid experience in microbiology lab and related microbiological test & method validation,
  • Practical experience in sterile product control and utilizing at least one of the following sterilization technologies: ethylene oxide, radiation (gamma, X-Ray and electron beam), or moist heat.
  • Have effective problem-solving abilities and strong communication stills (both written and oral)
  • Proactive, dependable, detail oriented.
  • While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment (Class 100K cleanroom) and office area.
Position location
Singapore
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