Updated 2007

Quality Engineer
The ideal candidate will possess the following qualifications:

• Fundamental understanding of an ISO 9001/QSR quality system and its development documentation and implementation.
• Experience in providing quality support through control plans, 1st article layouts, statistical analysis and quality process improvements.
• Basic understanding of internal and external audits, planning, preparation, execution, reporting results and conducting follow ups.
• Experience in coordinating and conducting MRB
• Experience with conducting process validations and verifications activities (IP,OP QP), risk analysis techniques (FMEA), problem solving techniques including root cause analysis, 5 whys, cause and effect analysis and CAPA.
• Good written and verbal communication skills
• Demonstrated problem solving skills
• Knowledge of Microsoft Office products
• BS in Engineering with 4 years experience in a manufacturing setting with quality responsibilities.
• ASQ/CQE certification preferred
• Medical manufacturing experience a plus

Please send resume with salary requirements to jane@gauthierbiomedical.com

No walk-ins please.
Interviews by appointment only.