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 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.
#J-18808-Ljbffr