Hi ,

* *

*We have below requirement with one of your direct client. If you are
interested, please send me your updated resume with contact details to
[email protected]  ASAP.*



*Title* :  Software Quality Engineer

*Duration* : 5 Months

*Location* :  Northridge, CA LOCAL ONLY

*Rate* : Depend on Exp/Best



*Description* :

 *Job Duties :*

-Conducts Continuous Improvement Reviews

-Conducts root cause analysis on specific project areas

-Determines the need for - and provides - QSR compliance and SQA support

-Ensures appropriate review of software products

-Identifies and documents noncompliance

-Implements improvements in processes, standards, and procedures

-Monitors quality of software products, processes, and standards

-Provides Part 11 compliance support

-Recommends improvements in processes, standards, and procedures

-Supports SW development validation lifecycle

-Facilitates and participates in qualification of acquired SW and SW tools

Working in the FDA environment will be an added advantage.

-Possibility of overtime hours with supervisor permission.

-Candidates must be authorized to work in the US.



1. Coordinates and/or monitors all software verification and validation
(V&V) activities to ensure that software is validated in accordance with
established industry and company requirements and that the Verification
&Validation process is carried out in accordance with established
procedures.

2. Conduct software risk management by utilizing techniques such as Software
Fault Tree Analysis, Software FMEAs.

3. Conducts planning meetings to review proposed software changes,
implementation schedule and establish testing requirements.

4. Conducts review meetings to review Verification & Validation results, and
to recommend software release.

5. Coordinate and execute system and software testing projects of small,
medium or large scope that require advanced software testing, documentation,
and Project Management skills, and participate in larger projects to drive
proactive quality and safety throughout the organization.

6. Use working knowledge of national and international requirements and
standards such as FDA QSR Part 820, EN 14971, ISO 13485, ISO 9001, 21 CFR 11
and others.

7. Less than 10% travel may be required in order to receive training and
continue development.

8. Identify and support cost-saving programs and process improvements.

9. Applies advanced technical principles, theories, and concepts.
Contributes to the development of new principles and concepts.

10. Works on unusually complex technical problems and provides solutions
which are highly innovative and ingenious.

11. Works under consultative direction toward predetermined long-range goals
and objectives. Assignments are often self-initiated. Determines and pursues
courses of action necessary to obtain desired results. Work checked through
consultation and agreement with others rather than by formal review of
superior. May supervise the activities of lower level personnel.

12. Perform other duties as assigned.




Thank You*,*

*Deepa Mukurala*

*Senior Business Recruiter*

*MOTORIA*

*Providing Intellectual Capital To Companies Worldwide!*

INTEGRITY | ACCOUNTABILITY | INNOVATION | COMMITMENT

MMSDC/NMSDC Certified Minority Business Enterprise (MBE)

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