Design Quality Assurance

15 hours ago

Pune, Maharashtra, India Infosys Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Description:BE BTech Mechanical OnlyExperience in medical device onlyProfessional training and certification in in Quality Management Systems including ISO 13485 Risk management ISO 14971 design assurance control verification and validationSound understanding of medical device regulatory requirements for Class II and III medical devicesProject planning resourcing timelines quality and budgetsSkilled in implementing Quality tools like design of six sigma risk management FMEA FTA Fault Tree AnalysisPreference for candidates with CQE certification or similar training and experienceProficient in project management tools like MS projectExperience in GD TWell versed with statistical analytical techniques and s w tools like MATLAB MINITABKey Responsibilities:Be a part of core project team and support the quality engineering across the entire development cycleLead product risk management usability reliability and design validation efforts for new product development and design change projectsLead the development and implementation of design verification and validation plans with project design leadLead the development of Critical to Quality CTQs design input and output documentsLead the fixture qualification and test method validationParticipate and implement tools like Design of Experiments DOE s FMEA sessions Risk Management and ensure compliance to CTQ s and safety requirementsManage electronic document control and version control on all project related documentsEnsure adherence to the quality systems and design assurance SOPsLead usability reliability testing verification and validation testing internal and local vendorsProvide statistical testing and reliability plansProvide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distributionEnsure appropriate Project Sustaining Quality Deliverables are created and properly executed egProject Design Development Plan Risk Management Plan Hazard Analysis Use and Design FMEA Field Assessment Plan and Software Validation Plan if applicableCo Lead CAPA efforts and apply sound systematic problem solving methodologies identifying prioritizing communicating and driving resolution of quality issues eg5 why s analysis Is Is Not analysis and Six Sigma problem solving methodologiesDevise and support the implementation of effective quality assurance process controls statistical analyses and metrics that assure products meet or exceed qualityTechnical Requirements:QMSKnowledge of Regulatory standardsCFR820 ISO Hands on experience on Risk ManagementGood understanding of Post Market Survey and complaint handlingDesign planMedical ProcessDQCDeviation and CAPA preferredPreferred Skills:Foundational->Development process generic->Medical Device development process->ISO 13485,Technology->Quality models/improvement frameworks->ISO 13485

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