Quality Engineer for Expanding Medical Device Co.

Los Gatos  ‐ Onsite
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Keywords

Description

-Support and perform Corrective/Preventive Actions (CAPA)
-Prepare, review and issue quality documentation
-Give quality input into new product development activities and new manufacturing activities
-Assess systems to identify deficiencies and participate in resolution of issues found.
-Support the current production activities in quality issues and to support the Project Engineer as necessary with the transition of new products into production.

-Support the management of calibration of test equipment and the resolution of issues with calibration of test equipment.
-Provide support in developing inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Design Validation Testing.
-Perform internal and vendor audits to assess compliance to Standards and to the internal Quality System, including investigation, presentation of observations and findings,
-Help facilitate continuous improvement and learning across all functional areas through training and communication of quality initiatives.
-Monitor training/certification activities for Quality/Project personnel.

SKILLS:

-Excellent understanding and knowledge in medical device development and implementing quality standards - ISO, FDA requirements (CFR 820) .
-Knowledge of working within an organization operating an engineering quality system and meeting regulatory requirements.

Please be in contact as soon as possible for this urgent position. Candidates must have Medical Device experience.

To find out more about Real Staffing please visit www.realstaffing.com
Start date
02/2013
Duration
6 months+
(extension possible)
From
Real Staffing
Published at
19.01.2013
Project ID:
475413
Contract type
Freelance
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