Senior Quality Engineer - Medical Devices
UCB, Inc. - Sunnyvale, CA

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UCB has an excellent permanent position opportunity for a Quality Engineer with medical device production experience. The position offers excellent working environment, benefits, and career advancements. Responsibilities will include:

- Initiate, design, optimize, and development of robust processes, resulting in an accurate and complete process validation. (i.e. IQ, OQ, PQ)
- Quality engineering for product design/development, manufacturing processes development and support, pre-production, clinical studies, and market release
- Responsible for quality issues resolution, compliance activities, inspection implementation, and FMEA evaluation
- Manage all site activities related to microbiological testing, evaluation, product sterilization and sterile product release
- Ensure quality system development and compliance with FDA’s QSR, ISO 13485:2003, and other quality requirements
- Support and develop systems for the identification, analysis, correction and prevention of quality issues
- Provide leadership and guidance to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective / preventive actions are implemented
- Writes procedures, protocols and any other documentation needed for the enhancement of systems
- Provides training and education to the team on tools for process evaluation and enhancement (analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements)
- Participates in technology transfer / improvements projects by identifying test method requirements and quality acceptance criteria

If you live in California and meet the requirements below, please send your resume. We require on-site interviews.

5-10 years in the Quality/Reliability Engineering disciplines
Working knowledge of MDD, FDA QSR and related domestic and international standards
Medical device industry experience
Knowledge of FDA and ISO 13485 requirements and effective implementation of these concepts through all verification and validation activities relating to medical device regulations is required
Be able to capture, format and analyze data including the ability to recognize errors or discrepancies in data and propose explanations for the discrepancies
CQE preferred
Good communication and problem solving skills
Ability to work independently with minimal supervision
B.S. degree in Engineering or Biomedical Sciences

Compensation: Competitive / DOE
Position Type: Permanent, full time, on site
Start date: April 2013
Location: Sunnyvale, California
Contact: resume AT ucb DOT net / 650-377-0773


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