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Quality Systems Specialist
3 weeks ago
Cork: | Dublin:
The role requires a comprehensive understanding of regulatory requirements, strong technical writing skills, strong project management skills, and the ability to coordinate cross-franchise teams to ensure compliance with EUMDR & IVDR.
Responsibilities:
- Develop & manage project plans, timelines and budgets.
- Coordinate 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 guide 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
Requirements:
- A minimum of a Bachelor's Degree, preferably in Engineering or 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.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers Partners'
Dublin Office Fitzwilliam House,
4 Upper Pembroke Street,
Dublin 2,
D02 VN24,
Ireland
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