*Reply to:v...@beyondtekit.com <to%3av...@beyondtekit.com>(LOCAL TO SAN
FRANSISCO ONLY)*


Hi ,



This is for my direct client opening for *Software QA Engineer with Medica
Device - San Francisco, CA*. This is a *9 Months *position. The Hourly rate
is* $40.00/hour. Local candidates only.*

* *

*Job Responsibilities:*

*
*-This role requires SWQE to become an integral member of the project team,
develop Verification Test Plans, associated verification procedures,
protocols and reports to assure overall regulatory compliance to the QSR,
and applicable Quality System standards.

-The primary role of Software Quality Engineering (SWQE) is to ensure that
Software, as part of Medical Device development, is in accordance with good
design practices, and Design Control requirements defined by the FDA Code of
Federal Regulations, Volume 21, Section 820 (QSR).
-Executing this role requires SWQE to become an integral member of the
project team, develop Verification Test Plans, associated verification
procedures, protocols and reports to assure overall regulatory compliance to
the QSR, and applicable Quality System standards.



*RESPONSIBILITIES:*

-Participates in the development of Project Plans
-Collaborates in Hazard / Risk Assessment and contributes to the Risk
Analysis / Risk Management Report
-Provides design team support for determination of applicable safety agency
requirements
-Provides design team with medical device regulatory input
-Participates in generating or generates Product Requirement Specifications
as directed by the project manager
-Creates, approves, releases and implements best practices for QE
documentation
-Participates in Design and Phase Reviews
-Generates verification test plans, procedures, protocols, reports and trace
matrices providing evidence that the design meets requirement specifications
-Provide client with safety agency and regulatory approval support when
requested

*REQUIREMENTS:*

* *

-Candidate must have a minimum of 5 years medical device experience

-Ability to work in teams with all levels of management.

*Please complete the following skills-matrix and send back with your updated
resume. *

*       ***

Full Name:

Degree Major:

Total IT Experience:

Total Software Quality Assurance Engineer exp:

Total medical device exp:

Total exp in Participates in the development of Project Plans:

Total exp in Providing design team support for determination of applicable
safety agency requirements:

Total exp in designing team with medical device regulatory input:

Total exp in generating Product Requirement Specifications as directed by
the project manager:

Total exp in participating in Design and Phase Reviews:

Hourly Rate:

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:v...@beyondtekit.com?subject=software Quality Assurance Engineer  -
San Francisco, CA
<v...@beyondtekit.com?subject=software%20quality%20assurance%20engineer%c2%a0%20-%20san%20francisco,%20CA>
***

* Please ensure you complete and copy/paste the above-completed matrix with
your response



*Vasu*

*BeyondTekIT*

*Tel: 714-857-2002 - Ext -815*

*Fax: 714-364-9705*
*v...@beyondtekit.com*<javascript:top.opencompose('v...@beyondtekit.com','','','')>
*
http://www.beyondtekit.com/*

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