Role Summary:
This Senior Quality Engineer opportunity enables a professional to ensure top-notch quality and compliance across manufacturing, contributing to life-changing medical devices.
Key Responsibilities:
* Provide guidance and support to Quality Engineers and Technicians, assigning tasks and offering constructive feedback.
* Drive continuous improvement through CAPA and KPI analysis.
* Lead quality projects, ensuring milestones are met within set timelines.
* Maintain Good Manufacturing Practices (GMP) standards and compliance in your area.
* Collaborate with Operations, Supply Chain, and other teams to guarantee 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:
* Degree in Engineering, Life Sciences, or related field.
* Level 8 Degree 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.