Job Description:
We are seeking a highly skilled Quality Systems professional to play a vital role in ensuring the compliance of our Quality Management Systems (QMS) with relevant directives and regulations.
Main Responsibilities:
* Maintain CAPA and Complaint Systems, ensuring accuracy and efficiency
* Manage Quality Systems data collection and analysis for informed decision-making
* Prepare and present Monthly Quality Reports to stakeholders
* Complete GAP assessments on Quality Management System regulations for continuous improvement
* Support Software Validation activities to ensure system integrity
* Support the Management Review Process for strategic planning
* Support the maintenance and continuous improvement of QMS processes for optimal performance
* Support other Quality system activities, e.g. Audit Management, SOP Updates, Document System Management
Requirements:
* Educated to Diploma Level in Engineering, Science or Quality Assurance discipline, with strong foundations in quality principles
* A minimum of three years' relevant experience in the medical device or pharmaceutical industry, with knowledge of ISO standards and regulatory requirements
* Familiarity with Medical Device Regulation and FDA QMSRs for compliance assurance
* Excellent communication and organisational skills, with ability to present reports neatly and accurately
Benefits:
* Competitive salary and bonus package
* Pension scheme with generous employer contributions
* Private medical insurance for health and wellbeing
* Paid sick leave and group life cover for peace of mind
* Hybrid working arrangement for work-life balance
* Flexible start and finish times for flexibility
* Opportunities for further education, training and development for growth