Senior Compliance & Supplier Engineer

12 Jan 2018
10 Feb 2018
Contract Type
Full Time
Do you have experience of working in QMS in a regulated industry within medical device or pharmaceutical ? Job Title: Senior Compliance & Supplier Engineer Reference No: 236459 Location: Renfrewshire Job Type: Permanent The role is support key QA processes to ensure compliance with required regulations and company policies and procedures including: * Management and coordination of external audits by OEM customers and regulatory bodies. * Management and coordination of company internal audit programme. * Management of site audit readiness for all types of external inspections. * Management of the supplier audit schedule. * Maintenance of up to date cGMP/GDP training materials and delivery of quality management system training as part of induction or annual refresher training. Manages processes to ensure robust, risk based processes for supplier management to control and drive supplier continuous improvement initiatives. Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards: EC medical Device Directive (93/42/EEC); ISO 13485; FDA CFR 21 820, and associated Canadian, Australian, Japanese and Taiwanese regulations. 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 QUALIFICATIONS & EXPERIENCE Relevant Science/Engineering Degree or similar qualification Proven experience in Quality Management Systems in a similar role within a medical device environment 2-5 years' experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing Lead / Internal auditor qualified with proven audit experience Knowledge and experience of FDA regulations Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices 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 apply to Rachel Oliver, Senior Consultant;; (Apply online only) RHL is a specialist Recruitment Consultancy within Life Science talent acquisition. Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency