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.
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