Quality Assurance Engineer- Maternity Leave

A leading multi-disciplinary medical device company is seeking a Quality Assurance Engineer

to join QA/RA team and support the product development lifecycle end-to-end, in compliance with international standards and regulatory requirements.

What you will do:

• Lead Design Controls activities: planning, verification, validation, and design transfer – ensuring full documentation and end-to-end traceability.
• Manage and maintain DHF – Design History File and ensure compliance with company QMS.
• Conduct and support Risk Management activities according to ISO 14971: identification, assessment, controls, and monitoring.
• Support design reviews (FDR/TDR) and engineering changes (ECO).
• Participate in and/or lead internal and external audits, quality trainings, and Quality Management Reviews.
• Work closely with R&D, Regulatory, Clinical, Process Development, and Manufacturing teams.

Requirements:

• B.Sc. in Mechanical / Biomedical Engineering or related field from a recognized academic institution.
• 3–5 years of experience as a Quality Engineer in a multi-disciplinary medical device company (hardware/software/mechanics).
• Proven experience in Design Controls, requirements management, V&V, design changes, and design transfer.
• In-depth knowledge of ISO 13485, ISO 14971, MDR, 21 CFR Part 820, IEC 62304, IEC 60601.
• Experience working in a cross-functional / matrix environment (R&D/RA/Operations/Clinical).
• Excellent English skills – reading, writing technical documents, and presenting.
• Highly organized, detail-oriented, able to manage multiple tasks simultaneously, and strong interpersonal skills.