Quality Manager Medical Devices QMS ISO13485

SJB Technical Ltd ,
Bath, Somerset
More Details
Job Type: Full-time
Salary: £40,000 per annum

Overview

Quality Manager Medical Devices Bath £40k - £60k benefits flexible working An innovative medical device startup, combining additive manufacturing and digital technologies to create personalised medical devices, surgical planning software, VR and AR tools for surgeons with clinical trials due to start during 2020 This is an opportunity for an experienced Medical Devices Quality Manager to manage quality for a novel custom-made, implantable, Class IIb product that will benefit mobility, health and quality of life for patients of all demographics worldwide. Define and own the quality strategy that will take the product through design, regulatory approval and then to market. Collaborate with senior management and engineers and bring pivotal expertise in quality management systems and medical device regulations. Join the team as they build and validate the product, achieving a comprehensive approach to quality management is our most advanced medical device. Early deliverables Understand and implement applicable regulations Conceive and set quality strategy, encompassing production and supply chain Build upon existing QMS Establish the quality function and promote a culture of best practice Apply for, and maintain, approval of ISO, CE, MDR standards for our device Preparation for IEC approval of software components We're looking for Able to plan, organise and operate a rigorous approach to quality Experience in quality management for Medtech or a medical device Knowledge of ISO:13485, ISO:14971, FDA standards and certification processes Familiarity with guiding on quality for new product development Data accuracy, and familiarity with a modern QMS and MS Office A self-motivated inclusive approach, from someone who works well with others You may also bring - or like to gain - knowledge around any of Software validation process; IEC:62304 MDR and MDSAP Salary and benefits include £40,000 - £60,000 Discretionary company bonus Discretionary relocation assistance Flexible working practices - including optional part time or partial remote working

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