PE Global is currently recruiting for a Project Engineer for a leading multi-national med device client based in Cork & Dublin. This is a remote role with an expectation to be in the Cork office quarterly.
This is an initial 12-month contract position.
Key Responsibilities:Develop & manage project plans, timelines and budgets.Co-ordinate with internal and external stakeholders to ensure all milestones are met.Identify, manage and mitigate project risks and issues.Ensure the organisations data submissions to EUDAMED comply with EUMDR requirements.Stay updated on regulatory changes and provide guidance on EUDAMED-related compliance matters.Collaborate with quality assurance, IT and other relevant departments to ensure seamless integration and operation of EUDAMED processes.Develop and deliver change management processes to maintain data integrity.Qualifications:A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 10 years related experience.Experience working in both an FDA and European regulatory environment is preferred.This position will require relevant experience working in manufacturing/operations.In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.Experience with a proven track record of implementing appropriate risk mitigation.Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.The ability to perform 'hands on' troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.A thorough understanding of GMP/ISO regulations and validation regulations is preferred.Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.Demonstrated project management and project leadership abilities are preferred.This position may require up to 10% travel.Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to ******.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
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