- Reference: SJ43569
- Job Type: Permanent
- Location: Leitrim, Roscommon, Sligo
- Category: Production
Our client, a leading multinational in Roscommon, is looking for an experienced Quality Validation Engineer to join their team.
- Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with the company quality system and the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations.
- Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice.
- Provide training and guidance to others on validations as required.
- Provide support to the NPI engineers and sales to define validation plans and times to meet customer and company requirements.
- Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
- Provide manufacturing quality engineering support for current business to improve quality through improved manufacturing processes and process control.
- Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
- Primary degree in Engineering or equivalent.
- A qualification in quality management is desirable.
- Minimum of 5 years in a technical role, min 3 years medical device/pharmaceutical and/or diagnostics manufacturing experience.
- Must have a good working knowledge of ISO13485, FDA Quality System Regulations.
- Self-starter with good inter-personal skills.
- Ability to multi-task is essential.
- Should have strong analytical communication, organisational and influencing skills.
For a confidential discussion and more information on the role, please contact Niamh Cregg on 071-9149732 or email email@example.com
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