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To:murali neela From:murali neela Subject:[] QA Engineer (IMMED INTERVIEW)_------------------START DATE ASAP-----------------------------!! Date:Thu, 5 Apr 2012 16:55:51 -0400

Dear Business Partner,
Hope you are doing well,
Please let m know if you have any consultant like to move forward with the below position, Please send me your consultant resume with the complete contact detail ASAP.

Job Title: QA Engineer
Location: Englewood, CO
Duration : 6 Months

Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

Bachelors degree (or high school diploma/GED plus 4 years working experience in Quality Engineering or Quality Assurance Management.
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
Significant Multi-Modality Sites: Minimum 4 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
Small and Simple Sites: Minimum 3 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
Demonstrated experience using word processing, spreadsheet, and presentation software.
Demonstrated understanding of continuous quality / process improvement tools:
(As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)

Preferred Qualifications:
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
Demonstrated collaboration, negotiation & conflict resolution skills
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Change agent with energy, passion & enthusiasm to drive change
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively

Warm Regards,
Steven Smith

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