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Sr. Quality Engineer

Orange County Metro Area, California

Post Date: 06/29/2017 Job ID: JN -062017-19415
Quality Engineer, Design Control

A Global Medical Device headquartered in Irvine, CA is looking for a Quality Engineer, Design Control to make a significant contribution to their dynamic and fast-paced environment. The Quality Engineer, Design Control will be responsible to drive quality engineering processes and will be responsible for quality activities as part of a cross functional team that includes: R&D, Manufacturing, Production, Regulatory Affairs and other functions to drive technical decisions and project schedule.

Quality Engineer Job Duties:
Providing design control expertise in product design and design iteration
Managing Design History Files
Manufacturing process and design support, including process validation, risk analysis and quality control plan development
Maintaining regulatory and quality compliance
Quality Engineer Qualifications:
A Bachelor s degree in engineering required, electrical or biomedical degree a plus
Minimum 7 years of experience
Medical device experience required, pharmaceutical industry experience will be considered
FDA regulated experience
Design control, change control and process qualification
Design for manufacturing, quality method development, method validation
Excellent communication skills, both written and spoken
A strong sense of urgency and problem solving skills

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