Job Description
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 proactively support quality engineering activities with regards to the Quality Management System specifically Supplier Management and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of continuity and improvement of the established QMS, delivered product quality and to support growth of the Company.
This is a permanent role based in The Midlands with excellent progression opportunities
Key Responsibilities of Senior Quality Engineer:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
Implement continuous and innovative improvements with demonstrated and measurable results - e.g. Dock to Stock Program, Cost of Poor Quality
Drive the supplier audit program through managing and conducting supplier audits per schedule. Ensure proper root cause is determined and implemented by the supplier when there is a finding.
Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
Ensure supplier files are compliant with regulations and internal procedures.
Partner with Site purchasing & integrate Division Supplier Quality team to leverage cross site competencies and drive improvements.
Liaise with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
Support NPIs by providing guidance on compliant adherence to company requirements as defined in material specifications, CTQ's, process control plans, quality agreements and other defined requirements.
Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality related aspects.
Provide Operational QA Support for products and process.
Requirements of the Senior Quality Engineer
Degree in Quality, Engineering or a Science discipline.
3-5 years' experience at quality engineering level within a regulated industry, preferably the Medical Device Industry
Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations Audit experience in conduction supplier and or internal audits
Knowledge in statistical methods
Please send an up to date CV and cover letter to John Reid at The RFT Group / johnr@rftgroup.ie / 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.