Quality Engineer, Sr. - Añasco Puerto Rico LabChemS Corp., Clasificados Empleos Puerto Rico

DescripciónDescription Fundamental understanding of quality systems with implementation to domestic and international standards. Basic understanding of audit process: types of audits, planning, preparation, execution, reporting results, follow-up. Develop and implement quality programs: tracking, analyzing, reporting and problem solving. Plan, control and assure product and process quality in accordance with quality principles: planning processes, material control, acceptance sampling and measurement systems. Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements. Develop technical documentation: Validation Protocols, Technical/investigation reports, SOP, Validation Plans, Change Controls. Implement Quality System Regulation, ISO, Design Control and Process with strong Project Management skills.

Requisitos Requirements BS in Chem, Biomedical, Mech, or Ind. Eng, 5-7 years of experience in FDA regulated Medical devices environment. ASQ Certified Quality Engineer and/or Quality Audits, preferred. Validation guidelines and lyophilization preferred. Must have prior experience with ISO cleanrooms. Knowledge of qualifying new facility additions-HVAC, water filter systems. Knowledge in Lean and Six Sigma concepts and statistical techniques: SPC, DOE, Process Capability and Gage R & R, etc. with use of Minitab. Experience in biomaterials preferred. Working knowledge of business software (including MS Project, VISIO). Fully bilingual (English/Spanish). In-depth understanding of problem-solving and quality improvement tools and techniques. Basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, assessment tools and reporting. Temporary contract (one yr. 251599)

Requiere Mucha Experiencia Requires Expert

BeneficiosBenefits Package This role mandates physical presence in manufacturing settings. Compensation will be determined based on the educational qualifications and experience of the selected candidate. LabChemS Corp (LCC) stands at the forefront of consulting services, laboratory solutions, and support resources catering to the medical and pharmaceutical device sectors in Puerto Rico.

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