To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99684849
_Software_Quality_Assur_Analyst.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 19-Dec-2007
Software Quality Assur Analyst
Description
Looking for a Software Quality Assurance professional to
commit to a
broad range of activities including, but not limited to the
following:
Ensuring that software used in the development, and
manufacture of
Medical Devices, and as part of medical devices, is
developed
according to good design practices and follows the
requirements set
forth by procedures, regulatory authorities and notified
bodies.
Provide leadership, oversight and training to manufacturing
plants for
computerized system validation. Assessment of software
applications
for potential implementation in a regulated environment.
Provide
oversight for the validation of software, hardware and
networks,
including risk-based approaches. Ensuring that the quality
system
elements necessary to achieve and maintain compliance within
an FDA/
ISO regulated environment are established and activities
related to
software are controlled via these elements. Participate with
Users in
the preparation of software and hardware specification
documents.
Establishment of system quality expectations and performance
metrics.
Work with appropriate teams in monitoring and interpretation
of
performance metrics. Preparation of and training to
"standard
operating procedures". Implementation of corrective and
preventive
actions, as required. Gatekeeper of system change,
configuration
activities and supporting documentation. Preparation for
and
leadership of external/internal computer system/software
audits.
Contribute to process improvements by developing and
updating written
procedures related to computer systems validation.
Participate in
analysis, design, and change review for product and
non-product
software
Qualifications
The successful candidate will have a broad range of
experience.
Working knowledge of the FDA Quality System Regulation, 21
CFR Part
11, ISO13485:2003, and the European and Canadian Medical
Device
Directives is desired. Demonstrated experience in product
risk
management (ISO 14971), requirements management and tracing,
defect
tracking, configuration management techniques, and how they
are
applied in the software development lifecycle. Understand
current
Software Quality techniques, software industry standards
(e.g. ISO,
IEEE, AAMI) and their impact on internal procedures,
software quality,
and the safety and efficacy of products. Ability to
understand and
apply Medical Device Design Control to software development
and
validation. A desire to work in a dynamic team environment.
Demonstrated project management and leadership skills. A
four year
degree in computer science, computer information systems, or
other
technical field, or the equivalent in combined education
and
experience is required. A minimum of three years of
progressively
responsible IT and/or QA experience is desired. Occasional
travel may
be required. Experience with the following is desired: ERP
Software,
Change Management Software, Configuration Management
Software, Product
Lifecycle Management Software, Clinical Trials Software,
Laboratory
Information Management Systems, Manufacturing Execution
Systems,
Oracle, Visual Basic, MS Access, Sequel, Windows and UNIX
platforms,
LAN / WAN networks, Client Server Software, HMI, machine
control
software, and laboratory equipment. Demonstrated experience
in
Software Quality Assurance processes, SDLC methodology,
change
management, documentation, verification and validation
techniques.
Excellent written and oral communication skills.
Proven experience:
* Handling multiple projects and priorities with competing
resources *
Ability to communicate clear direction, commitments, and
alignment *
Ability to partner broadly * Ability to be both flexible
and
determined * Highly motivated, assertive * Ability to train
others
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
--~--~---------~--~----~------------~-------~--~----~
Introduce business in 3800 cities. How?
=====================================================
Thanks for using group.
Moderator
1) This group is managed by www.webvideo4u.co.uk
2) Post your message with your linkedin Profile (Visit
linkedin.com) to confirm your identity and refer business.
3) Visit www.BRCIndex.blogspot.com (3800 Business Referral
Club)
4) Reply to two message before posting new one.
5) Donot post same message in all 3800 business Referral
Club.
You received this message because you are subscribed to the
Google Groups "Outsource" group.
To post to this group, send email to Outsource googlegroups.com
To unsubscribe from this group, send email to
Outsource-unsubscribegooglegroups.com
For more options, visit this group at http://group
s.google.com/group/Outsource
-~----------~----~----~----~------~----~------~--~---
|