Quality Systems Engineer, Bristol

Rising star of British design and manufacturing based in Bristol need a Quality Systems Engineer to support the development, validation, implementation and training for the eQMS. Client Details Elvie develop extraordinary and smart technologies designed to improve the lives of women. It's a fascinating and challenging area that requires us to solve the problems that no one else has ever tackled before. Our first product, Elvie Trainer, is an award-winning app-connected trainer that helps women strengthen their pelvic floor muscle via fun, five-minute workouts. It took the wellness industry by storm and is now available via the NHS Supply Chain. Our street cred is backed up by more than 12 awards for innovation and design, including the prestigious Red Dot Award and an IDA Design Award. Our second innovation: Elvie Pump, the world's first silent hands-free, wearable breast pump, has received international praise, including being listed as one of the Times 100 best inventions in 2019 and 'wearable design of the year' at the Dezeen Awards. Elvie has received more than 30 awards, including being named one of 15 startups "To Watch" by The Sunday Times and ranked as the 6th fastest growing business in the UK by SyndicateRoom in 2019. Tania Boler has recently been rated as the 8th most influential person shaping british technology in 2019 by Business Insider and both products have been featured in the Oscar Nominee Gift Bags. In April 2019, Elvie announced a $42 million Series B, the largest ever fundraise in Femtech. How do we like to work? You will be surrounded by people who want to improve everything and everyone around them. People who are passionate about our mission. People who are driven to solve tough problems and constantly consider the best ways to improve the health and well-being of women. We're deeply proud of our values, which are intrinsic to the way we behave every day. We take them seriously because we want our culture to thrive. Description Quality System Engineer responsibilities are; Quality Management System: Support the development, validation, implementation and training for the eQMS Lead the ongoing administration of the eQMS and its continuous improvement Play a pivotal role in the continuous development of the Quality Management System to achieve ISO 13485:2016 certification Lead the tracking and reporting of quality metricsDocument Management: Lead the day-to-day running of the electronic Document Management System and Change Control process Support the R&D and NPI teams with the maintenance of the product Design History FilesCAPA and Non-Conformance: Lead to day-to-day running of the NC and CAPA processes Support New Product Development with metrics and analysis of NC, CAPA and customer care dataInternal and External Audit: Support the internal and external audit program including CAPA, SCAR and NCR investigation and administration Support the onboarding and maintenance of suppliers and contract manufacturers in accordance with the QMS Profile As QSE ; You are a detail-oriented, passionate and dynamic individual with a desire to be an integral part of Elvie Quality team. You respect rules and regulations but are not afraid to do things differently and challenge 'business as usual'. You are able to understand the needs of the business while balancing them against the need for compliance. You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You can develop plans of action and communicate them with confidence to 3rd party suppliers and the different functions within the business. You have been working within the Medical Device industry for around 3 years, in a Quality and Regulatory focused role. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business. What we need from you: A degree in a relevant engineering, design or science discipline (or equivalent qualification) Appreciation for all stakeholders involved in new product development Experience in consumer or medical products design and manufacture would be of benefit Ideally 2-4 years within a highly regulated industry Developing and improving Quality Management Systems and the ability to interpret regulations Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP Experience in CAPA investigation and root cause analysis Experience in administration of an eQMS would be an advantage Experience auditing to ISO 9001 or ISO 13485 would be an advantage Experience in product development and the application of Design Controls would be an advantage Able to review and understand hardware, firmware and software requirements and specifications Familiar with commonly used productivity software such as Microsoft Office and Google SuiteNote: you must have the right to work in the UK to apply for this role Job Offer We are looking after you. As well as the chance to develop products with real work impact and working with dedicated and passionate colleagues, our benefits have flexibility and well-being in mind