US-Arizona-Flagstaff: QA ENGINEER
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682388_QA_ENGINEER.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 20-Jun-2008
QA ENGINEER
Requirements Bachelor=92s degree in an applicable science or engineering
(or a two-year degree plus significant medical device experience or
significant medical device experience in a Quality Assurance role).
Must have at least ten years medical device or pharmaceutical industry
experience in quality assurance and a demonstrated track record of
successful Quality Assurance leader****p. The successful candidate will
also have demonstrated experience in successful partner****p with other
leader****p functions (Business, Engineering, Manufacturing, etc), and
been involved in FDA and Notified body audits, preferably as the audit
lead. Additional do***ented experience in the following areas is also
required: Demonstrated excellent written and oral communication
skills, strong interpersonal skills, conflict resolution, quality
systems implementation and maintenance; statistics; Design control,
GMP/Quality System Regulations; ISO 9000/EN46000/ISO13485, vendor and
process auditing (including certified auditor training); product/
process/software validation; generation of change control do***ents;
do***ent control; and receiving inspection. Basic computer literacy is
also required. Desirable: Advanced degree(s) in an applicable science,
engineering and/or business. Experience in PMA
This position also requires that the Associate is involved in
developing policies and procedures which affect operational and
compliance status and working with quality management representatives
as appropriate. This individual will also provide additional
mentor****p to quality assurance associates (and others), assist in
leading facility efforts to address product issues, provide direction
to the implementation of effective corrective actions and review the
results of monitoring of post-implementation effectiveness. Additional
responsibilities include a focus on design control and other
activities in sup****t of new product development, systems enhancement
(including software implementation and validation), working with
engineering to enhance process yields, compliance auditing, working
with procurement and engineering to select and approve vendors,
associate training, and demonstrating strong sup****t for our culture.
Further responsibilities may include: Initiation of change
do***entation, advisory roles sup****ting various teams (such as raw
materials inspection, do***ent control, maintenance and calibration,
environmental monitoring and control, etc.); initiation of change
do***entation; preparation of quality re****ts and presentations;
review of complaints.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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