R&D Sustaining Engineer with a background in Engineering, Science or Quality / Regulatory required by growing medical devices company in Co. Clare, to join a multi-disciplinary project team & act as a link between R&D and Regulatory Affairs. Reporting to the Chief Technical Officer, you will be responsible for modifications of devices post release to market, for the purpose of maintaining device quality and compliance, as well as reducing cost and increasing yields.
Requirements:
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Graduate with a third level qualification (level 6 or higher) in a Science, Mechanical or Electronic Engineering, Quality/Regulatory discipline, or someone with proven experience in quality assurance or regulatory assurance within a regulated industry
- Experience with Microsoft Excel, Word, Outlook
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Good project planning and organizational abilities
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Strong interpersonal and oral / written communications skills
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Good scientific and logical attitude
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Strong time management and organisational skills
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Pro-active, with proven ability to work under own initiative, while being a strong team player
Responsibilities:
- Act as a link between R&D and Regulatory Affairs (RA), to determine what Standards and Regulatory Requirements existing devices need to comply with
- Determine the gaps in the Design History File, and work with R&D and RA to address these gaps
- Liaise with Production, Materials, Quality, Sales and Marketing staff as required
- Liaise with ex-house consultants, agencies and test houses as required
emer@emtechrecruitment.ie
