Validation Spec Iii (Labeling & Packaging)-Añasco

Support implementation of labeling/artwork changes on a product family for CE and non-CE marked SKUs, ensuring conformance with global labeling: Data Gathering–Discovery and compilation of required documentation to be updated as part of the Labeling/artworks changes implementation. Labeling/artworks changes implementation – Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement suggested changes. Perform tasks such as generation and execution of change control, technical reports or memos, First Article Inspections, and manufacturing documentation update through site change orders system (Agile). Develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Requisitos:
BS in Science or Engineering, preferably Mech, Ind, Electrical, Chem, Biomedical. Minimum of 5–7 years of experience in medical device and/or pharmaceutical manufacturing environment. 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. Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation REQUIRED. Must have knowledge of European Union Medical Device Regulation / Directive and ISO13485:2016 Medical Devices. Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis. Excellent communication skills (English and Spanish). Availability to work extended hours in a day and weekends as required. One year Contract 1415