Our company is seeking a Quality Systems Specialist to join our team. This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices.
Key Responsibilities:
* Maintain the Quality Management System (QMS) and activities to ensure that all operations are fully in compliance with FDA, ISO, and other regulatory requirements.
* Implement quality system procedures, work instructions, and records.
* Manage document control and change management activities.
* Track and report metrics and key performance indicators for the Quality Management System.
* Monitor and trend quality system metrics (CAPAs, complaints, audit findings, and prepare reports for management reviews.
* Support Corrective and Preventive Actions (CAPA) by conducting root cause investigations, effectiveness checks, and documentation.
* Assist with risk management processes.
* Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPI's and Quality Management Review.
* Lead the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
* Support / host Client quality audits. Inclusive of addressing findings and required actions.
* Manage Document Control - Site lead for managing SOPs and Document Control.
* Site lead for training compliance to SOPs.
* Other duties as required to support the growing Quality organisation.
Essential Criteria:
* Flexibility to travel to the US is required to support business activities and Quality Audits.
* Bachelor's degree in a Science-related discipline.
* Minimum of 3–5 years' professional experience in the Medical Device industry within a Quality Assurance role.
* Experience with Medical Device software is an advantage.
* Strong knowledge of current QMS requirements with extensive experience in ISO 13485; knowledge of ISO 27001 is an advantage.
* Proven ability to clearly and concisely communicate with both internal and external stakeholders.
* Strong organizational and presentation skills, with the ability to communicate Quality Metrics to management.