Brightwork's specialist client is currently recruiting a Senior Quality Engineer who will support key quality processes to ensure compliance with required regulations and company policies and procedures including
Responsibilities
* Management of site audit readiness for regulatory external inspections.
* Maintenance of up-to-date cGMP/GDP training materials and delivery of quality management system training including FDA preparation and related requirements
* Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards
* Promote a culture of high performance, continuous improvement and regulatory compliance with a commitment to quality.
* Provide consultation and advice on quality related subjects, supporting business and department objectives whilst ensuring regulatory compliance
* Support key Quality processes to ensure that these are compliant with required regulations and company policies and procedures.
* Support the provision of materials for Quality Management
Qualifications & Experience
* Relevant Science/Engineering Degree, or similar qualification preferred
* Proven experience in Quality Management Systems in regulated environment
* Lead or Internal auditor qualified with proven audit experience
* Strong analytical and problem-solving skills
* Knowledge and experience of FDA regulations, MDSAP and MDR
* Thorough knowledge of regulatory standards, Quality Management Systems
* Excellent facilitation, coordination, prioritization, presentation and communication skills
* Proven ability to manage and prioritise workload, meet deadlines and work in a pressurised environment
* Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department
* Please note this is a 12-month FTC role.
This is an excellent opportunity to join a well-established and successful global company. If you are interested, please send your most recent CV and salary expectations to the address supplied.
Brightwork offers the services of a recruitment agency for permanent roles and a recruitment business for temporary roles.
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