Growing Medical Device Company in West Sussex it now looking for a QA /RA Manager to join their growing business.
• Ensuring that business continually meets all quality assurance requirements as defined in ISO 13485:2016, 21 CFR 820, the Medical Devices Directive 93/42/EEC and 98/79/EC In Vitro Diagnostic Medical Devices
• To work with QA/RA Manager to ensure that all complaints and vigilance reporting requirements are carried out in accordance with the MDD 93/42/EEC and relevant guidance documents
• To provide quality assurance support and direction for all areas of the business.
• Working with all areas of the business to produce and maintain quality system documentation to the requirements of ISO 13485 and 21 CFR 820
• To be a pivotal contributor to all internal, external, regulatory inspections and audits.
• To manage and maintain all document control and change control activities.
• To ensure that all documentation used within the Quality System is compliant with the requirements of ISO 13485, 21 CFR 820 , 93/42/EEC Medical Devices Directive and 98/79/EC In Vitro Diagnostic Medical Devices directive and Good Document Practice (GDP)
• 4+ Years experience of working in a Quality or QA/RA role in the Medical Devices industry.
• Experience of Managing a Quality Management System.
• Knowledge of, ISO 13485, 21 CFR Part 820, CMDCAS.
• Experience working with class I, IIa and IIb Medical Devices.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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