NPI QA Engineer:
Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced NPI QA Engineer.
The NPI QA Engineer will be responsible for 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.
This is a permanent role based in The Midlands (commutable from Galway) with excellent progression opportunities
Key Responsibilities of NPI QA Engineer:
Review and/or develop and execute facility, software, process and equipment validations and risk management documents
Review change controls for process/design 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.
Complete NCMR and CAPA investigation, processing and disposition.
Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
Perform Internal Audits/Supplier Audits.
Assist in the development, analysis and improvement of site Quality Metrics.
Lead/Support project activity in your area of responsibility
Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
Will comply with all relevant training required and adhere to relevant associated documentation.
Follow strict adherence to the requirements of CGMP.
Liaise with suppliers to ensure drawings and specifications are clear, understood and fully compliant.
Requirements of the NPI QA Engineer:
4 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.
In strict confidence please contact John Reid at The RFT Group / on 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.