Sr Quality Engineering

Updated: April 25, 2024 08:59 PM GMT

Edwards Lifesciences

Costa Rica

Key Responsibilities : Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, Edwards Lifesciences SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or product outputs. Anticipate risks of execution and put mitigations in place so audit review requirements are met. Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria. Work with cross-functional partners to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Write Validation Plans for projects that require multiple validations and create timeline for validation Collaborate with cross functional teams in Costa Rica, Singapore, Horw, Switzerland and Irvine to implement and align Quality Control inspection plans, requirements, and... More Detail

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