To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682555_Senior_Software_Quality_Engineer.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 09-Jun-2008
SUMMARY OF POSITION:
Responsible for ensuring that software used in the development,
manufacturing and as part of medical devices is developed according to
good design practices and follows the corresponding requirements set
forth by local procedures, regulatory authorities and notified bodies.
Provide leader****p, oversight and training to division manufacturing
plants for computerized system validation. Best Practices - Translate
standards into processes and procedures and apply these to the design
process
ESSENTIAL FUNCTIONS: 1. Promote a structured software development
process. Assure that a state of control is maintained for in-house and
outsourced software development. 2. Participate in critical analysis,
design, and change review meetings for product and non-product
software. 3. Provide oversight of manufacturing software validation
process. 4. Generate metrics for *****sing software quality and
evaluate results. 5. Contribute to process improvements by developing
and/or updating written company or departmental procedures related to
software development. 6. Administer configuration control system for
device, manufacturing and product development tools software. Provide
oversight during software release to manufacturing as well internal
distribution. 7. Administer and control problem-tracking database and
oversee defect process resolution. 8. Sup****t outsourced software
vendor audits and qualification. 9. Provide software validation,
design controls, and risk management training.
Minimum Requirements: Bachelor of Science degree in Electrical
Engineering, Computer Science, or Computer Engineering 5+ years in
software quality engineering role dealing with embedded software that
is part of a medical device. Working knowledge of the FDA Quality
System Regulation, ISO 13485, and the Medical Device Directive Skilled
in product risk *****sment (ISO 14971), requirements management and
tracing, defect tracking, configuration management techniques, and how
they are applied in the software development lifecycle Understanding
of current Software Quality techniques, software industry standards
(e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their
impact on internal procedures, software quality, safety and efficacy
of products Working knowledge of C, C++, and LabVIEW
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
|
