I am a highly skilled QA Manager with a strong track record of building and leading high-performing teams, providing strategic guidance, and ensuring team objectives align with company goals, ensuring the successful execution of tasks through effective delegation and resource allocation. Analytical and structured, I excel at identifying training needs by assessing team qualifications against defined roles to meet business objectives. Additionally, my entrepreneurial mindset and problem-solving skills have been instrumental in helping smaller companies overcome development barriers through structured analysis and tailored organizational improvements.As an honest and reliable sparring partner, I approach challenges with a sense of humour, making me an approachable leader who fosters a positive team spirit.I have extensive experience in establishing and maintaining robust ISO 9001 and ISO 13485 compliant Quality Management Systems (QMS) for both start-ups and established companies. I specialize in authoring and reviewing advanced Risk Management and Cybersecurity SOPs, as well as ensuring IEC 62304 software documentation compliance. I am persistent in driving continuous improvement, facilitating Quality Management Reviews, and managing equipment calibration. My expertise extends to implementing issue-management systems for CAPA, NCR, and audit issues, leading internal audits, and ensuring effective follow-up on quality objectives. I have strong expertise in planning and conducting supplier audits in Europe and Asia, as well as improving procedures for the effective transfer of new products to production sites and CMOs, ensuring quality and compliance. My experience includes planning, review and approval of development documentation, and my QA support has been pivotal in ensuring compliance and successful product approvals by legal authorities such as the FDA and EU Notified Bodies.