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 rsquo;s or master rsquo;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 ldquo;quality management rdquo; 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 Another top job from ECM, the high-tech recruitment experts. Even if this job #39;s not quite right, do contact us now - we may well have the ideal job for you. To discuss your requirements call (phone number removed) or email your CV. We will always ask before forwarding your CV. Please apply (quoting ref: CV27193) only if you are eligible to live and work in the UK. By submitting your details you certify that the information you provide is accurate