Design Quality Engineer

Job Description

•6 + years' professional experience in medical device regulatory , Experience with systems for quality management, product development, and follow-up of procedures. • E xperience in medical device regulatory Quality systems EU MDR, US FDA 510(k) and closely working R&D, Regulatory Affairs organizations • Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 10993-1:2018; ISO15223-2021; ISO 14971:2019; EN ISO 13485; ISO 11607-1,2; and EN ISO 11137-1 and MEDDEV 2.7/4 • Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) • Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan • Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. • Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle • Performs independent technical assessment on product quality performance and post-market product quality analysis • Can Lead quality related problem solving and root cause analysis during design and manufacturing • Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required • Compliance focused • Be able to handle ad-hoc changes in priority/planning and independently. • Be able to think from customer expectation perspective • Be able to work in different teams simultaneously • Communicative & disciplined team worker.