Validation Engineer

Republic of Ireland  ‐ Onsite
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Keywords

Description

A leading Medical Device company based in the Midlands in Southern Ireland are currently looking for a Validation Engineer to join them on a contractual basis of 6 months.

The successful candidate should have primary degree in Quality Management, Engineering, or Science, with a minimum of 3 years validation experience in medical device/pharmaceutical/diagnostics experience. Strong, structured problem solving ability, 6 sigma and experience in a medical device assembly environment would be a distinct advantage.

Role Responsibilities:
  • You will be required to complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with the quality system and the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations.
  • To create and effectively execute validation plans and achieve key project deliverables on time and within budget times to meet customer requirements.
  • To project manage and lead cross functional teams to introduce and validate new processes and technology. Provide training and guidance to others on validations as required.
  • As required s/he will lead and or participate in CAPA and other cross functional improvement teams.
  • Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice. Assess customer's validation needs and propose innovative solutions.
  • Maintain validation and other records in accordance with the quality system requirements, which show that products manufactured meet the requirements of end users, customers, regulatory authorities and the company.
  • Investigate, trouble shoot, disposition and report on validation failures: system failures, non conforming products and other product defects.


The successful candidate will be an energetic individual, well organized, able to multitask and balance conflicting priorities, self-motivated with the ability to work with cross-functional teams and motivate others.

If you would like to apply for this role please contact Sarah Irvine on or apply by submitting your CV. We also offer €200 worth of vouchers for any successful referrals so if you know anyone who is looking at the moment please feel free to get in touch.
Start date
02/2015
From
Real Staffing
Published at
02.02.2015
Project ID:
844163
Contract type
Freelance
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