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NPI Quality Engineer Role Sligo

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Recruiter: Real Staffing
Listed on: 14th May
Location: Sligo
Type: Permanent

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Role: NPI Quality Engineer Location: Sligo Industry: Medical Devices An new permanent opportubity for a NPI Quality Engineer had come available with one of our medical devices clients in Sligo. The successful client will work within a cross functional team involved in the setup, manufacturing and supply of products to the company's established customer base. Other duties include: - Support the Quality Engineering elements of related processes, updating and improving the Quality Management System as required. - Maintain the Quality Notification process for the management of CAPA, vendor CAPA, MRB, Customer Complaints, and similar related activities. - Work very close with the Validation Function within the site to ensure complete transparency and accuracy of validation & verification documentation generated in support of the new product introduction approval effort. - Work cross functionally with all affected departments to ensure the quality engineering elements of the project are clearly understood, and team members clearly understand the requirements to be met. Job Requirements * Bachelor's degree in Quality Management/ Quality Assurance / Engineering or equivalent industry experience * 2 years' experience in a similar role in the Medical Device Industry. * Knowledge of ISO, MDD, FDA requirements essential * Knowledge of Quality Standards, Validation Regulations and Guidance Documents required * MS Office proficient. Experience with SAP beneficial. * Proven track record in a similar role. * Strong project management capabilities. * Excellent attention to detail in oral & written communication, with a proven technical protocol & report writing background

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