A Quality Management Systems Project Manager is required by Careerwise recruitment to work on a 12 months contract position in Dublin.
Role of this position
* 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 organisation's 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.
JOB REQUIREMENTS
* A minimum of a Bachelor’s Degree, preferably in Engineering or a related technical field. Generally requires 10 years of 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.
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