*Direct Client Need SR. SOFTWARE QUALITY ENGINEER with Medical in Carlsbad, CA - 1 Year Contract*
Job Title: SR. SOFTWARE QUALITY ENGINEER with Medical Location: Carlsbad, CA Duration: 1 Year Contract *Job Description:* Provide quality software engineering support in design and development of medical device products, specifically ventilation products. Facilitate the application of software design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues. Experience: • 5-10 years of quality engineering experience or equivalence. Skills/Competencies: :• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing. • In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 and the Medical Device Directive. • Skilled in test plan development and root cause failure analysis. • Good verbal (including presentation) and written communication skills, especially technical report writing. • Ability to effectively work on project teams. Preferred Skills/Qualifications: • Strong familiarity with regulatory requirements e.g. IEC 62304ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971. • Experience in risk evaluation techniques, such as FMEA & fault tree analysis. • ASQ CQE, CRE, CSQE certification desirable, but not essential. *Thanks & Regards Syed Riyaz Agile Enterprise Solutions Inc Ph: 972 427 1716 syed_ri...@aesinc.us.com <syed_ri...@aesinc.us.com> | http://www.aesinc.us.com <http://www.aesinc.us.com>* -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-abap+unsubscr...@googlegroups.com. To post to this group, send email to sap-abap@googlegroups.com. Visit this group at https://groups.google.com/group/sap-abap. For more options, visit https://groups.google.com/d/optout.
