Hi Hope you are Doing Good
This is Bhavani From Agile Enterprise Solutions Inc.. Please take a look @ the Job description given and let me know if you are interested reply with your most updated resume .. Job Title : Sr Software Quality Engineer III Job Location : Carlsbad, CA Duration : 6 months *Passport NO. and Visa copy Mandatory* ESSENTIAL FUNCTIONS: • Strong familiarity with regulatory requirements (e.g. ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820, ISO 14971, ISO 62304). • Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage. • Experience in risk evaluation techniques, e.g. HHE, Product Risk Assessment, SFMEA, DFMEA, PFMEA & fault tree analysis. • ASQ CQE, CRE, CSQE certification desirable, but not essential. • Participate in Software development reviews, code reviews and formal software technical reviews • Review new and modified product designs for quality characteristics, reliability, serviceability, testability and traceable to product requirements. • Ensure successful transfer of new products to production facility. Review production processes for quality of validation. • Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance. • Provide guidance and direction for sample size and statistical analysis of verification and validation test results. • Provide training to project teams on procedures, verification, validation, statistical methods and design controls. • Review Design History Files and Technical Files for conformance to applicable requirements • Assist, when appropriate with internal and supplier audits. • Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues. • Participate in Software development reviews, Code Reviews and formal software technical reviews. • Skilled in statistical methods. Thanks and Regards, Bhavani Kallem Ph: 901-203-2885 Agile Enterprise Solutions Inc Email: [email protected] || http://www.aesinc.us.com -- You received this message because you are subscribed to the Google Groups "as400placements1" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send an email to [email protected]. Visit this group at https://groups.google.com/group/hrccpl. For more options, visit https://groups.google.com/d/optout.
