Ameditech

San Diego , CA

Quality Validation Engineer #ALE-0003-LM

Ameditech
San Diego, CA Full-time
Posted on October 20, 2019

Quality Validation Engineer

Ameditech in San Diego, CA seeks qualified Quality Validation Engineer. Responsible for working with quality, engineering, facilities & manufacturing to support the activation of new or existing equipment, facilities, or processes. Masters in Biomed Engineering, Biomed Technology, or in highly related field of study (Will accept Bachelors in above fields with at least 5 years of related program experience in lieu of Masters) each alternative with at least 1 year of experience in: (i) quality eng activities specifically related to process validation include but not limited to validation master plans, equipment qualification, test method validation, facilities validation, cleaning validation & pFMEA generation; & (ii) implementing procedural improvements to process validation programs, risk management programs or pFMEA programs s/a writing procedures & developing templates for IQ, OQ, IOQ, TMV, PQ, MVP, pFMEA, risk management to ensure current national & international reg standards, include ISO 13485, ISO 9001, 21 CFR Part 820, GxPs, are met.

Employer will accept any suitable combination of education, training, or experience.

An EOE.

40 hours per week.