Quality Manager, Medical Device Instrumentation

Mission driven, innovation focused technology start up
Tackling difficult problems through innovation, this engineering team are putting their considerable knowledge and experience to combine process automation and manufacture for cell therapy applications. They aim to enable highly expensive processes to become more cost-effective and scalable, allowing personalised therapies to be affordable for more people.
To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of a digital document quality management system (QMS). This will require good communication skills to get buy-in from all stakeholders.
Requirements:
- Graduated with a bachelor’s or master’s in engineering or similar.
- Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable.
- Comprehensive experience with “quality management” within a technology company including instilling a quality-focused culture and maintainable approach to quality processes.
- Detail oriented and strong communicator.
Whilst this is a start-up, they are well resourced and already have good industry connections with suppliers and buyers. For this role, the expectation is that it is onsite with occasional ad hoc home-working (possibly 1 day per week working from home). No company sponsorship is available, only applicants with no visa restrictions will be considered. On offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus.
Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs / Herts Border
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