Instrument Manufacturing Quality Engineer (BB-7C2CE)

Found in: Talent UK

Instrument Manufacturing Quality EngineerLumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx currently has over 900 employees worldwide.We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.OpportunityThe successful candidate shall be responsible for carrying out the day to day Quality Management Systems activities associated with the production of instrumentation. The emphasis of this role is on providing QA input to manufacturing support, supply chain activities, process validation, complaint investigations and/or product release. The role involves a "hands on" approach to working with other departments within LumiraDxKey Areas of Responsibility * QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues * Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications * Collation of data to support the generation of Quality Metrics and KPI's * Prepare and create documents and records for upload on to the document management system * Review and approve change controls as Quality representative on project teams and QMS * Manufacturing Quality representative for project teams throughout product lifecycle and product realization activities * Highly motivated individual that can demonstrate flexibility and a can do attitude. * Ensures positive, productive and proactive relationships with a range of internal key stakeholders. * Self-driven, takes ownership and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives * Can listen and present effectively, providing progress updates and feedback on a regular basis * Ability to plan and organise work in accordance with the overall objectives and required timelines * Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity * Able to travel between company sites as needed (not expected to be frequent)About YouTo be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You should ensure positive, productive and proactive relationships with a range of internal and external key stakeholdersEssential skills * Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry. * Experience of working in a relevant role with a strong quality focus and with a minimum of 2 years' experience. * Manufacturing/ technical background. * Competent IT skills in EXCEL; POWEPOINT; WORD and ability to pick up new systems (e.g. document management; complaint; ERP systems). * Excellent attention to detail and a good team worker * Excellent organizational skills for working on and prioritizing multiple activities * Ability to use problem solving tools and methodologies * Proven knowledge and experience implementing ISO 9001Desirable skills * Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP * Experience of IVD or medical device activities in a quality role. * Degree preferred. * Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping). * Proven knowledge and experience implementing ISO 14971.At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our businessPlease note, if you wish to submit an application for this role, please consider the following information:This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you're successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance

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