Job Description
This role involves managing key elements of the Quality Management System, Batch Release, and ensuring compliance to applicable standards across all levels of the organization. Key Responsibilities:
* Oversee the Material Review Board and disposition products
* A member of internal audit team - conducting process, product, and workplace audits
* Responsibility for generating and reporting of quality KPIs to Site Head
* Manage the Customer Complaint handling through to resolution
* Perform post-market surveillance planning and reporting
* Provide expert guidance and knowledge to technical and validation teams
* Provide quality guidance on continuous improvement projects including change management, and risk assessments
* Lead regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standards
* Provide support to management during notified body audits and subsequent closure
Requirements
To be successful in this position, you will need to have extensive experience within a QA role within a medical device or pharmaceutical industry (experience with ISO 13485 required). You should also possess a degree in a scientific field or equivalent qualifications. Strong problem-solving ability and the ability to manage multiple stakeholder groups from operators to executive management are essential.