*REPLY TO t...@beyondtekit.com**
*

*Hi,
*

* Software Quality Assurance Engineer*

*9 Month Contract*

*Location: San Francisco, area*

*
*

* *

*REQUIREMENTS:*

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

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

*Our  client is seeking a Senior Software Quality Engineer to work on site
in the Bay area of California.
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*

* *

*Thanks and Regards
Tom
BeyondTekIT
Tel: 714-857-2002 - Ext -819
Fax: 714-364-9705
t...@beyondtekit.com
www.beyondtekit.com*


**

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