Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Senior Quality Engineer.
The Senior Quality 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 with excellent progression opportunities
Key Responsibilities of Senior Quality Engineer:
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, and FMEA's for any product line changes/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 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.
? Degree in Engineering or Science.
? 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
Please send an up to date CV and cover letter to John Reid at The RFT Group / firstname.lastname@example.org / 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.