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Lead QA Engineer (ISO13485)

Prognoix is a young medical start-up consisting of a small but vibrant and highly motivated team. The work environment at Prognoix allows for a great opportunity to learn and grow as a valued member of an international team. To drive and support the development of our medical technologies, we are looking for an independent and detail-oriented Lead QA engineer to implement and maintain our QMS systems according to ISO13485 standards.

  • Project Management
  • West Singapore, Singapore
  • S$3,500 - S$4,000 per month
  • 15/05/2019

Apart from being a teamplayer, the following responsibilities have been identified for the role.

  • Work together with our QMS consultant to complete implementation of our company-wide QMS system (includes training where required)
  • Upon successful implementation, you will take the lead in maintaining the QMS system
  • Coordinate with management and team members to ensure procedures are followed
  • Lead and drive perpetual improvement of QMS procedures
  • Maintain proper documentation using our document control system
  • Plan and support management reviews of the QMS
  • Coordinate and conduct internal audits
  • Support and liaise with external auditors to facilitate smooth audits
  • Proactive and motivated personality
  • Confident in taking on an active role in leading and shaping our QMS
  • 2 years of work experience directly related to ISO13485 QMS
  • Good knowledge of ISO13485 and FDA 21 CFR part 820
  • Preferably with training certificates for ISO13485 including audit training (additional training can be provided)
  • Good English and communication skills are mandatory