Reply to t...@beyondtekit.com*
This is for my direct client opening for *Software Quality Engineer
-Northridge, CA*. This is a *6+ Months contract* position. The Hourly rate
• 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
• 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
• 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
• 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.
• 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.
-ASQC, Design Controls, DHF, and Engineering Documentation
-PE - Professional Engineer, QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC
* Please complete the following skills-matrix and send back with your
*Total IT Experience:*
*Total Software Quality Engineer exp:*
*Total exp in Quality Assurance & Engineering of medical device
*Total exp in ISO quality systems:*
*Total exp in USFDA Quality System Regulation and relevant international
*Total industry exp:*
*Do you hold certifications in ASQC, Design Controls, DHF, and Engineering
*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 #:*
*Have you applied recently for this requirement earlier through any one
* 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,
* Please ensure you complete and copy/paste the above-completed matrix with
*Thanks and Regards*
*Tel: 714-857-2002 - Ext -819*
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