Quality Assurance Director
The company is seeking a Quality Assurance Director to lead the quality assurance agenda and ensure regulatory compliance. Reporting to executive leadership, the Quality Assurance Director will be responsible for maintaining a certified Quality Management System and ensuring compliance with international regulatory processes.
1. Lead the company-wide quality assurance agenda and ensure that customer requirements are met for products and services.
2. Ensure the effective functioning of continuous quality improvement based on performance measurement.
3. Manage risk related to design control in accordance with ISO14971.
4. Responsible for the ongoing maintenance, audit and continuous improvement of the Quality Management System to ensure compliance to relevant standards for Europe, UK, North America and Asia Pacific.
5. Regulatory clearance and maintenance for the Company's products in target markets.
6. Implement Home healthcare and electrical safety standards.
7. Manage QA team and implement proactive management of processes to ensure product and service quality.
8. Act as Management Representative for the Quality Management System.
9. Manage the maintenance of the Quality System to ISO13485 and FDA requirements.
10. Responsible for FDA facility inspections, notified body audits and other audits and inspections as required.
11. Establish infrastructure to assure quality and work with relevant teams to ensure performance improvement.
12. Ensure effective functioning of design controls to ensure product quality.
13. Represent the quality department in all NPI/NPD activities to ensure that new products are compliant to appropriate international quality and regulatory requirements.
14. Complaints handling for medical reporting and filing to the appropriate competent authorities.
15. Regularly review and manage change control process to ensure it remains effective and efficient.
16. Ensure products are cleared to the appropriate markets as per Regulatory plan.
17. Manage Regulatory Affairs support to internal and external customers.
18. Inform and give direction on changing regulatory and compliance requirements.
19. Manage the Quality team to ensure proactive delivery of departmental objectives and empower the team to actively support and assist other departments in complying with quality requirements.
20. Data collection and analysis for monthly meetings and management review.
Requirements
* University Degree or a Post Graduate qualification, preferably in Quality Assurance.
* 8+ years of experience in Medical Devices or other similar regulated industry.
* Significant regulatory affairs experience including experience of international regulatory processes.
* Knowledge of product certification testing requirements for Medical Devices.
* Deep knowledge of maintaining a certified Quality Management System.
* Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
* Previous experience of the impact of regulatory control on commercial products.
* Trained QMS Internal Auditor.
* Awareness of quality assurance processes.
* High level of attention to detail.
* Proven leadership skills.
* Excellent verbal and written communication skills.
* Results orientated and self-starter with ability to work on own initiative.
* Knowledge of and commitment to continuous improvement and problem solving.
* Promote best practice and knowledge of the QSR and ISO standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.
For further information please contact James Cassidy.