US-WA-Seattle: QA Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682359_QA_Engineer.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 23-Jun-2008
Sr. QA Engineer-Sterile Devices
Overview: Perform advanced and routine quality engineering and quality
system related tasks to sup****t production of medical device systems.
Responsibilities:
As relates to the Beacon Transponders responsibilities include, but
are not limited to:
1. Addressing issues related to the manufacture, control and quality
of sterile devices 2. Proven experience of sterilization (radiation
and /or EtO) requirements, clean rooms and manufacturing sup****t of
implantable devices. 3. Uses analytical tools to identify, measure,
improve and control manufacturing-related issues. 4. Able to plan,
execute and complete complex projects. 5. Abilility to provide sup****t
by planning activities to correct potentially disrupting manufacturing
issues. 6. Perform internal and supplier audits, including quality
system, production, design history files. 7. Review and analyze (track/
trend) results of nonconforming material control and corrective and
preventative action systems to ascertain a measure of achieved
quality. 8. Coordinate and oversee MRB activities. 9. Thorough
knowledge of process control charts (Xbar & R, I-MR, attribute charts)
10. Issue technical re****ts of high complexity for product and test
performance to sup****t sustaining activities. 11. Maintain and perform
receiving inspection systems and responsibilities. 12. Familiarity
with GHTFG3 process validation guidelines (IQ/OQ/PQ) 13. Perform an
inspection/analysis of all returned goods/field issues and provide a
re****t of findings; track/trend results. 14. Write procedures and
instructions, as required. 15. Oversee lot release and inspection of
Finished Goods product.
SECONDARY RESPONSIBILITIES
Create, implement, and teach new quality systems
Qualifications: 1. BS degree in Engineering or equivalent degree/
experience 2. Minimum ten (10) years experience in the manufacturing
industry, of which five (5) years should be in the medical device
industry. 3. Direct experience with FDA QSR compliance. 4. Knowledge
of cGMP's for the development, validation and manufacture of medical
devices. 5. Excellent verbal communication skills and effective
writing skills 6. Ability to excel in a team oriented environment
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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