Quality Management Systems Expert
We are seeking a highly experienced Quality Management Systems expert to ensure the maintenance and improvement of our Quality Management System (QMS) in compliance with relevant regulations and standards.
Key Responsibilities:
* Maintain QMS activities ensuring all operations comply with FDA, ISO, and other regulatory requirements.
* Maintain quality system procedures, work instructions, and records.
* Ensure timely document control and change management.
* Track and report QMS metrics and Key Performance Indicators (KPIs).
* Monitor quality system metrics, prepare reports for management reviews.
* Support Corrective Actions by conducting root cause investigations.
* Assist with risk management processes.
* Continuously assess QMS effectiveness and improve processes through collaboration with departments.
* Manage the Internal Audit program.
* Document Control - Site lead for managing Standard Operating Procedures (SOPs).
Essential Criteria:
* Flexibility to travel is required.
* Bachelor's degree in a Science-related discipline.
* Minimum 3–5 years' experience in Medical Device industry within a Quality Assurance role.
* Strong knowledge of current QMS requirements.
* Proven ability to communicate effectively with stakeholders.
* Strong organizational skills.