Quality System Engineer in Timisoara

Job DescriptionFlex is the manufacturing partner of choice that helps a diverse customer base design and build products that improve the world. Through the collective strength of a global workforce across 30 countries and responsible, sustainable operations, Flex delivers technology innovation, supply chain, and manufacturing solutions to various industries and end markets.In our Timisoara Design Center, in Romania, we develop for the medical market.For our expanding Quality team, we are looking for aQuality System EngineerBeing responsible for ensuring that all processes and quality system conforms to customers and internal quality system requirements (i.e. design control) and are properly applied to projects to achieve coordinated results from all the areas involved.Here is a glimpse of what you’ll do:Control & test the product’s functionalities during product development to meet customer’s requirements and applicable standardsGuide design team in conformance to the international standard applicable to the product development process (i.e. FDA’s QSR, ISO 13485 2016 & ISO-14971: 2007/2019)Serve as lead and coach in the implementation of design control and risk management requirements per above standards.Work within the design team to ensure that standard operative procedures are correctly used and maintained during the product development.Ensure the implementation of Risk Management activities during the product developmentEnsure that project data and documents are managed according to document and change control procedureAct as Agile change analyst.Support customers in quality assurance activities.Provide support to Design Quality Engineers regarding product verification plans, quality engineering procedures, instructions, checklists, quality related documents.Provide support to Management for any quality system related activities.Working together with the development team (hardware, software, firmware) in an international environmentSupport / Participate in Certification and surveillance audits and customer audits.Attend the specific training with the Quality Team and performs specific training to team members as wellSupports Design and/or Quality Engineers with customer interfaces as necessary on quality related issuesSupport in customer audits and regulatory/compliance agency audits. Here is some of what you’ll need:Engineering degree or equivalent in Electronic or related disciplineMinimum 2 years’ experience in a similar positionHaving knowledge of relevant regulatory standards and applicable regulationsFluent English in written and spoken formResults driven with the ability to take initiativeAbility to define problems, collect data, establish facts and draw valid conclusionsDemonstrated knowledge of multiple functional technologies/processes, industries or functions and understanding of interdependencies of such processesHere are a few of our preferred experiences:Knowledge of problem solving with quality tools such as: 6-sigma / 8-D / CAPA / dFMEA/ 5WHY etc.Supporting post market surveillance (assisting in complaint data analysis and trending and CAPA's)Knowledge of QSR 820 part 21, part 11 and ISO-13485: 2016Knowledge of Risk Management ISO-14971: 2007/2019 and 93/42/EEC, 98/79/EC and 90/385/EEC.QSR and / or ISO quality requirementsMedical Device industry experienceHere are a few examples of what you’ll get for the great work you provide:Competitive salary packageInternational career opportunities25 vacation days per yearMeal and gift ticketsHealth insurance including dentist services or private pensionWe are looking for someone who demonstrates: Intense collaborationPassionate customer focusThoughtful, fast, disciplined executionTenacious commitment to continuous improvementRelentless drive to win