
Quality Engineer Iii
hace 3 semanas
Support facilities/construction projects, mainly in Collagen areas. Required to be part of the Core Team of the facilities projects, participate on meetings and review/approve all documentation required such as PCDT, Change Control, EMPQ, equipment qualifications, documents changes, RM changes, calibration/PM documents. Will develop technical documentation: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls. Needs fundamental understanding of quality system and its development, documentation and implementation to domestic and international standards, experience with audit processes including types of audits, planning, preparation, execution, reporting results and follow-up; develop and implement quality programs, including tracking, analyzing, reporting and problem solving as well as plan, control and assure product and process quality
Requisitos:
BA Chemical, Biomedical, Mechanical, Industrial Engineering, minimum 5-7 years' experience in FDA regulated environment. ASQ Certified Quality Eng. and/or Quality Auditor, experience with biomaterials or Lyophilization, preferred. Experience with Quality System Regulation, ISO, Design Control and Process Validation. Knowledge of qualification of new facility additions-HVAC, water filter systems. Must have experience with ISO 7 and with/in cleanroom., preferred. Knowledge of reliability, maintainability, and risk management. Strong problem-solving and quality improvement techniques. Able to acquire and analyze data using standard quantitative methods to facilitate process analysis and improvements. Knowledge in Lean and Six Sigma concepts and statistical techniques, Strong interpersonal and Project Management skills, technical writing and problem-solving. Temporary contract-one year 1488
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Quality Engineer
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