Performsand / or coordinates specific tasks and functions within the company’s QualitySystem areas.
Evaluating Quality Issues Reports at Mfg. &QA Final
Preparing Rework Protocols or memos forNCRs
Investigating NCR, Quality Feedback andComplaints
Leading CAPA / PA Investigation for QualitySystem Issues & Improvement
Generation of Purchases Requisition
KNOWLEDGE, SKILLS AND ABILITIES
Five yearsor more of experience in Quality Engineering
Knowledge ofFDA current GMP / QSR Regulation
Strongapplied knowledge on statistical tools : DOE, Acceptance Sampling, SPC, etc.
Good oraland written communication skills in both English and Spanish are a must
Highly motivated, self-starter, and responsibleperson. Teamwork oriented
Generally, works in a closed environment, inoffice conditions, with normal level of noise and controllable changes oftemperature.
Needs to stand, walk and may be seated for along period of time.
Works with a personal computer and programs toprepare documents or reports.
Applies communication skills (advanced reading,writing, and technical skills) and mathematical concepts knowledge to performwork and coordinate with others.