Role: Quality EngineerLocation: Mullingar, Westmeath (On site)Benefits: Good salary, pension, healthcare and yearly bonus.Company:My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions.Role:Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the site team to champion & roll out the strategic initiatives which comply with the quality system requirement of ISO 13485 and ISO 11607 and in combination with customer request. To support our operation, engineering and R&D teams. The quality engineer will facilitate the development of new manufacturing process at the site and enhance the process and related quality system overtime. Customer onboarding and interaction is a significant element of the position.Duties:- Lead quality improvement programmes using recognised problem-solving and project. management techniques.- Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated, and corrective and preventive actions are closed in a timely and effective manner. Customer onboarding process is a key element of the position.- Management of customer documents into the Quality system i.e., Drawings; Purchase- Specification; Quality Agreements etc. and the training of relevant personnel.- Drafting and approving of quality documentation to meet Customer requirements i.e.,- Quality Specification Sheets (QSS), CAPA’s, Defect Library etc.- Trending and track of quality data to support quality improvements across the business- Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.- Adherence to incoming control requirements and supporting the SCAR process when required.- Participate in the review of validation protocols and reports to ensure quality compliance.- Executing internal process and system audits.- Manage quality projects in support of continuous improvement e.g., Lean Projects.- Co-ordinate activities associated with change management and customer interaction.Experience required:- Third level qualification in Engineering / Quality / Science.- Two + years’ work experience in a Medical Device manufacturing environment.- A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage- Ideally understand sterile sealing manufacturing process.- An in-depth knowledge of validations and change control management in a Medical Device environmentDoes this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie
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