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Walker Cole International is working with a leading medical device manufacturer seeking a Quality Engineer to join their growing Quality team. This is an exciting opportunity to contribute to quality compliance and continuous improvement within a fast-paced GMP manufacturing environment.
Key Responsibilities:-
Maintain and improve customer and supplier complaint processes, ensuring adherence to quality KPIs.
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Investigate, analyze, and resolve quality issues arising from manufacturing and design.
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Manage and report Vigilance, Field Safety Notices, Recalls, and Corrective Actions to regulatory bodies.
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Develop and maintain Post Market Surveillance (PMS) and Periodic Safety Update Reports (PSURs).
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Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820, and MDR 2017/745 regulations.
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Strong problem-solving skills using 8D, SPC, FMEA, CAPA, and root cause analysis.
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Hands-on experience with audits, complaint handling, and regulatory reporting.
Quality Assurance / Quality Control / GMP / ISO 13485 / ISO 9001 / FDA / CAPA / Root Cause Analysis / 8D / Regulatory Compliance / Continuous Improvement / Post Market Surveillance / Process Validation / Internal Auditing / Supplier Audits / Risk Management / Medical Device Manufacturing / Complaint Handling / Statistical Process Control (SPC)
