Our client located in Roscommon requires a Validation Engineer for their Quality department. This a permanent job but great career opportunities.
The Quality Validation Engineer has responsibility for the effectiveness of assigned areas of the company?s quality system and for completing validations of process and products as required. S/he will also provide validation and manufacturing quality support to the new product introduction manufacturing teams. Championing a structured approach to problem solving and error proofing using 6 sigma and lean principles.
- Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with 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 requirements.
- Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
- Effective and efficient execution of validation and other projects : Achieve key project deliverables on time and within budget
- Champion structured approach to problem solving within the organisation using cross-functional teams and six ? sigma methodology.
- Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
- Project manage and lead cross functional teams with responsibility for the introduction and validation of new processes/ new technology.
- Work with equipment vendors to mutually understand their and our technical process challenges to improve capability, eliminate cost and improve effectiveness of validations.
- 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 to meet the requirements of end users, customers, regulatory authorities and the company.
- Maintain the plants calibration system and equipment calibrations as assigned
- Investigate, trouble shoot, disposition and report on validation failures, system failures, non-conforming products and other product defects. Champion a structured approach to problem solving within process improvement teams.
- Identify and implement process controls including SPC as required
- Investigate, report on, and respond to customer complaints as assigned
Education, Experience and Skills:
- A degree in engineering or equivalent with 2/ 3 years medical device/pharmaceutical and/or diagnostics manufacturing experience including
- A good working knowledge of ISO13485, FDA Quality System Regulations.
- Self-starter with good inter-personal skills. Ability to multi-task is essential.
- Have an ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues.
For further information on this Quality Validation Engineer role in Roscommon please contact Cliona O?Malley on 091730022 / email@example.com
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