- Reference: AJ44953
- Job Type: Permanent
- Location: Galway, Offaly, Westmeath
- Category: Engineering, Technical & Manufacturing
Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for Supporting company goals, objectives, policies, procedures, quality systems, and FDA regulations.
QA Engineer NPI responsibilities:
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, Validations and FMEA’s for both new product introductions and existing product line changes/process improvements.
- Review and/or develop and execute facility, software, process and equipment validations and risk management documents
- Review change controls for process/design impact.
- Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
- Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
- Complete NCMR and CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
NPI Quality Engineer Requirements:
- Level 8 Degree in Engineering or Science.
- Five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.
- Strong computer skills (MS Excel, PowerPoint, Word etc)
- Familiarity with statistical tools such as Pareto charts and trend charts.
- Familiarity with all aspects of Process Validation (IQ / OQ / PQ)
- Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
- Experience with problem solving technique
For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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