* Reply to t...@beyondtekit.com* Hi, This is for my direct client opening for *Software Quality Engineer -Northridge, CA*. This is a *6+ Months contract* position. The Hourly rate is *DOE.*
Description: Job Description: • Responsible for the quality and reliability of software used in medical products, in development & manufacturing processes, and in implementation of the quality systems. • Managing & coordinating all verification and validation activities of multiple projects within the Software Quality Assurance department. • Defining software validation requirements; coordinating software verification and validation activities; initiating software risk/hazard analyses; and analyzing & recommending solution to complex software problems. • Provide support to project teams in defining & reviewing product and software requirements; qualifying software subcontractors; participating in code reviews; reviewing software changes; and analyzing field returns. • Coordinate and/or monitor all software verification and validation (V&V) activities to ensure that software is validated in accordance with established requirements and that the V&V process is carried out in accordance with established procedures. • Conduct SCRG (Software Change Review Group) and/or SPG (Software Planning Group) meetings to review proposed software changes, implementation schedule, V&V requirements; V&V results; and to recommend software release. • Conduct software risk/hazard analysis and risk evaluation, coordinate and verify the implementation of risk control activities. • Performing and documenting the results of code reviews and code walkthroughs. • Provide technical support to Research, Development, Engineering, Manufacturing, and other departments in developing test methods and test procedures used in the verification of product software, development software, manufacturing software, and software used in implementation of the quality systems. • Participate in the review of product requirements, design requirements, software requirements specifications, functional specifications, and software verification and validation test specifications, and verification and validation test data & reports. • Coordinate software release and implementation activities. • These include revision control, configuration management, and installation of the approved software in manufacturing areas. • Assist in the analysis of field returns and in-process non-conformities. • Assist in performing vendor audit and in providing input to the process of qualifying potential software subcontractors. • Participate in technical design reviews, CCB (Change Control Board) reviews, PQRB (Product Qualification Review Board) reviews, and PAB (Phase Approval Board) reviews. • This job may act as a technical lead in providing guidance and direction to other engineers and technical support staff. Experience Required: • Minimum of 5 years related experience in Quality Assurance, Engineering of medical device environments. • Working experience in ISO quality systems, USFDA Quality System Regulation, and relevant international standards. • Industry Experience: Greater than 5 years. Desired Certifications: -ASQC, Design Controls, DHF, and Engineering Documentation -PE - Professional Engineer, QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance -TQM * Please complete the following skills-matrix and send back with your updated resume.*** * * *Full Name:* *Degree Major:* *Total IT Experience:* *Total Software Quality Engineer exp:* *Total exp in Quality Assurance & Engineering of medical device environments:* *Total exp in ISO quality systems:* *Total exp in USFDA Quality System Regulation and relevant international standards:* *Total industry exp:* *Do you hold certifications in ASQC, Design Controls, DHF, and Engineering Documentation? (Y/N):* *Do you hold certifications in Professional Engineer, QS, 21CFR - GMP/QSR? (Y/N) (Please specify):* *Do you hold certifications in 29/40CFR, title 8, and NRC Compliance & TQM? (Y/N) (Please specify):* *Hourly Rate: * *Whether C2C or W2 (Corporation Name):* *Day Phone #:* *Evening Phone #:* *Cell Phone #:* *Availability:* *Current City/State:* *Have you applied recently for this requirement earlier through any one else? Y/N:* * If you qualify for this position, are available immediately and are interested, please send your resume, rate and contact information to *mailto:t...@beyondtekit.com?subject=software Quality Engineer -Northridge, CA <da...@beyondtekit.com?subject=software%20quality%20engineer%20-northridge,%20CA> *** * Please ensure you complete and copy/paste the above-completed matrix with your response *Thanks and Regards* *Tom* *BeyondTekIT* *Tel: 714-857-2002 - Ext -819* *Fax: 714-364-9705* *...@beyondtekit.com* <t...@beyondtekit.com> *www.beyondtekit.com* <http://www.beyondtekit.com/>** * * --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "zilliontechnologies" group. 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