Quality Assurance / Regulatory Affairs Officer
Bishop's Stortford, Hertfordshire, South East, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
Quality Assurance/Regulatory Affairs Officer Attractive salary, with excellent benefits, Location: Bishop's Stortford, Essex/Herts Border We are seeking a Quality Assurance/Regulatory Affairs Officer to support this global medical device company in meeting its quality and regulatory requirements. Provide technical support for medical device manufacturing … for compliance. Medical experience in a production/manufacturing environment. Internal and external quality auditing experience to ISO 13485. Passion for quality excellence. Previous quality assurance experience, including QMS documentation. Knowledge of CAPA and root cause analysis tools. Practical problem-solving approach. Understanding of ISO 14971 quality risk management principles. … actions. Conduct complaint investigations. Liaise with other departments on quality-related matters. Provide information for audits. Report vigilance incidents to the Regulatory Affairs/Quality Assurance Manager. Support ERP maintenance of quality modules. Provide quality and regulatory guidance to the Group companies. Ensure supplier documentation and highlight supply chain risks. more »
Employment Type: Permanent, Work From Home
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