Our client is a well-known Medical Device comapny in the west of Ireland, with a high tech manufacturing facility. This is an excellent opportunity to join a leader in their field, and continue your career with a high performing team.
Services Provision of quality system services relating to the following quality system elements:
o Purchasing and Supplier Controls quality system procedures and processes.
o Risk Management processes and criteria
o Supplier Selection and Approval
o Quality Agreements
o Performance measurement and feedback
o Supplier CAPA
o Product Qualification procedures
o Critical review of quality records
o Training materials
o Training materials for delivery to Suppliers
o Other Quality System elements as applicable to specific Client projects
Liaise and work with Client’s employees/contractors to complete Client project activities and deliverables, taking the lead to drive pertinent deliverables as applicable to project undertakings.
Operate with a high level of discretion, flexibility and professional judgment as to how the work is performed and results achieved.
Ensure compliance with Medical Device regulatory compliance requirements:
• Proposed solutions to address gaps in quality system procedures /processes
• New and updated quality system procedure drafts
• Template/Form design and creation
• Risk criteria and tools
• Redlined documents
• PowerPoint training slides
• Other deliverables as may be applicable to specific Client projects
Required Knowledge and Experience:
- Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255