Quality Assurance/Regulatory Affairs Officer
3 weeks ago
This role will support the Global Haag-Streit Organisations to meet their quality/regulatory requirements. Reporting to the QA/RA Manager, you will provide technical support, guidance and discipline for medical device manufacturing, engineering and distribution in the areas of Quality Assurance, regulatory compliance and quality systems requirements.
Key tasks will include supporting the preparation and submission of technical documentation required for regulatory market registrations, including risk, post-market documentation and reports, use of root cause analysis to address problems and identify trends and plan, carry out and document quality audits.
We are looking for a self-motivated individual who is passionate about quality excellence. You will also need to be able to: work as part of a cross-functional team, communicate at all levels and manage multiple projects simultaneously. Other required key skills include attention to detail, flexibility and planning and organising. You will need to have the ability to analyse and implement improvements. Good analytical IT skills are needed and experience of ERP systems would be beneficial.
You will need previous experience in the Medical Device industry and have a comprehensive knowledge of medical device quality standards and regulatory requirements. Previous experience in a Quality Assurance role would be highly beneficial. You will also need experience/knowledge of: internal and external auditing, CAPA and non-conformance root cause tools, quality risk management principles, MDSAP, biological evaluation, clinical evaluation reports and post market surveillance.
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