Quality Program Engineer

I have a position for a Quality Program Engineer with a well established medical device company in Santa Ana. This is a 8 Month contract position that has the chance to go full time. Manager would like the candidate to: Review and maintain the final sterilization program for all of the regional sites. Work with complaints group to develop systematic method of identifying potential microbiological related complaints; assure system evaluates risk to patient and makes appropriate recommendations to senior management in timeframe consistent with risk. Support the product development process by providing input related to process and product design mitigations related to microbiological risks. Strong industrial microbiology background and work with design control highly desirable and preferred. -Responsible for compliance with applicable Corporate and Divisional policies and procedures. Must be able to travel domestic and international. Plans, executes, reports and follows-up on quality system audits (supplier and internal).-Actively participates in and supports departmental operations and responsibilities in accordance with existing internal procedures and external regulations and the ability to lead and/or facilitate group compliance activities associated with the AMO quality system (e.g. audit programs, personnel training).-Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives. -Auditor certification from an industry recognized organization desired. -A minimum of 7+ years' experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing).-Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.-Candidate must have Passport as may be traveling both domestic and international. Expect 25% travel. If you are a good fit for the position please respond ASAP to be considered for an interview.

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