Quality Assurance Engineer
Our client, a medical device company in Westmeath is currently looking to recruit a Quality Assurance Engineer for their site.
Major Duties and Primary Responsibilities:
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
- Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
- Review change controls for validation impact.
- Use knowledge of statistics to assist with validation developments and process improvements
- 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.
- Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
- Perform Internal Audits.
- Assist in the development, analysis and improvement of site Quality Metrics.
- Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of CGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Degree in Engineering or Science or minimum 5 years’ experience in a Medical Device environment.
- 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 FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
- Experience with problem solving techniques
- Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
For further information on this Quality Assurance Engineer role in Westmeath please contact Anna McGowan on 0864667369 / firstname.lastname@example.org
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