RA Sustaining Engineer

3 weeks ago

Ennis, Clare, Ireland Vitalograph Full time
Job Description

Vitalograph is the world's leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. Headquartered in the UK, Vitalograph has operations in Ireland, Germany and the USA. Our mission is to improve patient lives by designing and manufacturing market leading products and services.

Why Join Us?

At Vitalograph, We Offer More Than Just a Job. As a Global Leader In Medical Respiratory Diagnostics, You'll Be At The Heart Of Ground-breaking Technology Used To Diagnose Respiratory Disorders Worldwide. Here's What You Can Expect
  • Pension contribution from the company, ensuring your future is secure.
  • Private Health Insurance for peace of mind.
  • Educational Assistance Programme to fuel your professional growth.
  • Clear career development opportunities, with room to grow and make an impact.

Reporting to the RA Manager, this role requires someone who has recently graduated with degree in engineering, science or quality/regulatory or someone with proven experience in quality assurance or regulatory assurance within a regulated industry.

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. You will be part of a multi-disciplinary project team, working under the co-ordination of a Project Manager.

Responsibilities
  • Take lead from the RA Sustaining Engineer
  • Act as a link between R&D and RA, to determine what Standards and Regulatory Requirements our existing devices need to comply with.
  • Determine the gaps in our 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.

Minimum Requirements
  • This role would suit a 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.
  • Excellent communication skills both written and verbal
  • Experience with Microsoft Excel, Word, Outlook

The Successful Candidate Will Have The Following Skills
  • Good project planning and organizational abilities.
  • Strong interpersonal and oral / written communications skills.
  • Good scientific and logical attitude.
  • Strong time management and organisational skills.
  • Pro-active, with proven ability to work under own initiative, while being a strong team player.
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