- Reference: 42538
- Job Type: Permanent
- Location: Offaly, Roscommon, Westmeath
- Category: Production
JOB PURPOSE: The Technical QA/RA Engineer is responsible for determining and supporting the Quality Engineering and regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally
Key responsibilities will include (but are not limited to) the following:
• Apply technical solutions to problem solving
• Apply technical solutions to quality improvement projects
• Use technical writing skills to clearly describe technical information
• Analyze customer complaints, identify trends and execute corrective actions
• Understand standards and their application to medical devices
• Planning, protocol generation, testing and report generation for medical devices
• Generation and maintenance of Technical Files for medical devices
• Review and update technical files in line with EU medical devices regulatory requirements
• The use of the GHTF STED format and harmonized standards when compiling a technical file in
compliance with the Medical Devices Directive
• Ensuring that records are filed in accordance with site procedures.
• Supporting R&D projects
ESSENTIAL SKILLS / EXPERIENCE:
• Engineering/Science qualification with 2/3 years of working within R&D/QA/RA in a medical device
• 2/3 years experience in R&D, QA/RA, Validations – essential
• 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device environment – essential
• Attention to detail and accuracy – essential
• Fluent English, both written and oral – essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project,
Outlook and Excel);
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the
ability to interface with all levels of management.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Donie Shine – firstname.lastname@example.org or call 0906478104.
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