Quality Assurance Engineer II (Fixed-Term)

Thermo Fisher Scientific
08 Aug 2017
14 Aug 2017
Contract Type
Full Time
Job Description:

Position Objective: Establishes and maintains appropriate Quality Systems consistent with ISO13485 and FDA 21CFR Part 820. Assures compliance to in-house and/or external specifications and standards. Actively leads the data collection, trend analysis, investigation and improvements to processes, products and systems. Essential Functions: * Work closely with Production, Technical and Manufacturing Engineering to resolve quality related issues arising from customer complaints/concerns and internal incidents. Responsible for the facilitation of investigations and resolution of related quality issues. * Works with technical support and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards. * Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. Identify and implement opportunities for improvement across the operational facility. * Performs statistical analysis to analyze trends, and works with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products. * Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR). * Utilise the Trackwise system for non conformances, deviations, Corrective and Preventative Actions (CAPA). * Participates on the Internal Quality Audit team. * Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods. * Provide training and support to other QA staff as required. * Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems. * May be required to perform other related duties as required and/or assigned. *IND-EMEA *LI - KP1

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