Manufacturing Engineer

My Client at a Global medical company at the Santa Ana CA location has an urgent requirement for a Manufacturing Engineer for a 6 month contract opportunity.

v Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.

v Review & approve product verification and validation plans and reports.

v Participate in CCB to review and approve engineering change requests.

v Participate in Material Review Board (MRB) to review & disposition nonconformities and to coordinate & supplier corrective actions.

v Work with Manufacturing to direct, coordinate & monitor the production processes that are in compliance to FDA QSR,ISO13485 and other applicable regulatory requirements (JPAL,Canada, etc.); and to ensure that safe and effective products are produced.

v Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp,SPC, DOE, process data analysis, and DMAIC.

*Basic Qualifications:

(Basic skills and experiences necessary to perform the job: must be relevant, objective, and non-comparative)

* Bachelor of Science Degree in Engineering or Science-related field
* 7 years related experience in Quality Assurance and/or Quality Engineering in a regulated environment.
* 2 years experience in bio-medical or other regulated industry.
* Working knowledge ofISOquality system (ISO13485), USFDA Quality System Regulation, and relevant international standards.
* Self-Starter and accountable, with sharp focus on quality and customer experience.
* Hands on experience in pFMEA, dFMEA, risk analysis and management.
* Working knowledge of problem solving and statistical methods as applied to process and product quality.

In order to be considered please submit your resume ASAP.

KEYWORDS: Process validations, equipment validations, manufacturing engineer, mechanical engineer, Santa Ana, Irvine, San Diego, Los Angeles, ISO, GMP, Medical Device, validation, FMEATo find out more about Real Staffing please visit www.realstaffing.com