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Quality Engineer/Sr. Quality Engineer-Software

Gurgaon, HR
Job Code:
  • Manufacturing & Production
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Job Details

QualityEngineer/Sr. Quality Engineer shall develop the overall quality approach fornew products and line extensions within the new product development andspecials process. This includes quality engineering oversight, quality systemsimplementation including test and inspection plans and product reliabilityduring product development, verification, validation and design transfer whileworking with Regulatory Affairs Department to ensure compliance to FDA QualitySystem Regulations and ISO 13485.Primary ResponsibilitiesRisk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.Sound knowledge of IEC 62304 Medical device Software Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC).Product risk assessment as per ISO14971.Support validation programs for new product development.Responsible for initiating, reviewing (Includes Design reviews & Phase Reviews), documenting and approving Engineering Change Orders (ECOs).Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability.Partners with the operations team to develop and maintain a robust internal and external supply chain. Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.Develop procedures for incoming, in-process and final inspections for new product development.Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.Authors and reviews procedures to ensure GMP and ISO 13485 compliance.Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.Lead product quality related projects. Supports the business in addressing and solving quality problems.Exposure to any Programming language & on Software Testing concepts.Work with cross-functional/cross cultural teams to develop regulatory guidelines and procedures.Provide inputs for NPDP for adherence to QMS and Good Documentation practices.May interact, by telephone or in person, with customers to resolve product issues as part of support escalation model.Participated in design reviews, code reviews for complex SW/HW development projectsExperience with various SW development environments and tools for embedded SW, and user application SWExperience with SW development life-cycle, change management, configuration managementExposure to usability/ human factor
Additional Degree: BE/ B.Tech (Engineering) | BCA (Computer Application)

Experience: 3-8


Application Programming | Database Administration (DBA) | Quality Assurance/Testing | System Administration
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