Lead Quality Assurance Role Summary:
This is an excellent opportunity to secure a Senior Quality Engineer position in the medical device industry. The role will involve ensuring top quality and compliance across manufacturing, helping deliver life-changing medical devices.
About the Responsibilities:
* Mentor and support Quality Engineers and Technicians, assigning tasks and giving clear feedback.
* Drive continuous improvement through CAPA and KPI analysis.
* Lead quality projects and ensure milestones are met on time.
* Maintain Good Manufacturing Practice (GMP) standards and compliance in your area.
* Collaborate with Operations, Supply Chain, and other teams to ensure product and process quality.
* Lead or participate in Risk Analysis (FMEA).
* Review and approve validation protocols, reports (IQ/OQ/PQ), and engineering changes.
* Maintain documentation in line with FDA and ISO requirements.
Requirements:
* Bachelor's Degree in Engineering, Life Sciences, or related field.
* Postgraduate Qualification in Science, Engineering, Quality, or similar.
* 5+ years' experience in the medical device industry.
* Strong knowledge of quality systems, measurement techniques, FDA & ISO standards (ISO 13485, 21 CFR Part 820).
* Proven CAPA and root cause problem-solving experience.
* Solid background in test method and process validation.
* Highly organized with the ability to work independently.