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
You will be responsible for the management and co-ordination of the Internal Quality Audit Programme and perform Internal Quality Audits to ensure compliance per schedule
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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