
Quality Systems Expert
7 days ago
Job Overview:
We are seeking a dedicated Quality Assurance Manager to maintain and improve our Quality Management System (QMS) for compliance with regulations and standards.
This role supports internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices.
Responsibilities:
- Maintain the QMS and activities for compliance with regulatory requirements.
- Maintain quality system procedures, work instructions, and records.
- Ensure timely and accurate document control and change management activities.
- Track and report metrics and key performance indicators for the QMS.
- Monitor and trend quality system metrics and prepare reports for management reviews.
- Support Corrective and Preventive Actions 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.
- Management of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights to drive continuous improvement.
- Support Client quality audits and address findings and required actions.
- Document Control - lead for managing SOPs and Document Control.
- Lead for training compliance to SOPs.
- Other duties as required to support the Quality organisation.
Key Requirements:
- 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 communicate with both internal and external stakeholders.
- Strong organisational and presentation skills, with the ability to communicate Quality Metrics to management.
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