Quality Assurance Lead

We are looking for an experienced Senior QA to oversee and support the manufacturing of high-quality medical diagnostic products. The ideal candidate will play a key role in ensuring efficient production cycles, managing quality assurance processes, and driving operational excellence.

Key Responsibilities:

• Lead the transition from IVD Directive (IVD-D) to the new EU IVD regulations (IVD-R).
• Ensure compliance with QA and regulatory requirements across the organization.
• Train employees on quality-related processes and best practices.
• Manage both in-house and outsourced manufacturing activities.
• Create work instructions and ensure alignment with the Quality Management System (QMS).
• Oversee and resolve nonconformities, CAPA, and ECO processes related to production.
• Support internal and external audits.

What We’re Looking For:

• Academic degree in Engineering, Life Sciences, Quality, or a related field (paramedical degree is a plus).
• 4-6 years of QA experience in Diagnostics (IVD) or Medical Devices (MD).
• Prior experience in manufacturing QA and managing quality processes.
• Strong knowledge of Medical Device Regulations (e.g., ISO 13485, IVDR).
• Hands-on approach to quality and experience with nonconformities, CAPA, and ECO processes.
• Excellent written and verbal communication skills in English.
• Strong multitasking abilities and attention to detail.
• Prior experience in supporting audits (e.g., CE, ISO 13485, FDA-QSR, CFDA) is a plus.
• Experience in Software QA and design control processes is a plus.

If you’re looking to join an innovative team in the medical diagnostics field, we’d love to hear from you!

Apply now and contribute to shaping the future of high-quality diagnostics.