Descripcion
Support the European Union Medical Device Regulation (EU MDR) program with the following activities: Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated. Gap Assessments–Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, etc. Remediation Plan–validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update.
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Requisitos - Requirements
BS in Science or Engineering (Mech, Ind, Elec, Chem, or Biomedical. MUST HAVE KNOWLEDGE OF EUROPEAN UNION MEDICAL DEVICE REGULATION (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices–Quality Management Systems. Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation are required. Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer. Proficient with Minitab for advanced statistical analysis. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
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