Key Quality Manager Role
We are currently seeking a highly skilled and experienced Quality Manager to join our team. This is an exciting opportunity to take on a key leadership role in the quality assurance agenda across our organization.
The successful candidate will have a proven track record of leading quality assurance initiatives, possess knowledge of regulatory processes for product clearance, and demonstrate excellent people management skills.
1. Lead the quality assurance agenda, ensuring compliance with customer requirements and regulatory standards.
2. Develop and implement effective quality improvement strategies based on performance measurement.
3. Ensure adequate control of design activity to ensure product quality.
4. Manage risk related to design control in accordance with ISO14971.
5. Oversee the ongoing maintenance, audit, and continuous improvement of the Quality Management System (QMS).
6. Responsible for regulatory clearance and maintenance for products in target markets.
7. Implement home healthcare and electrical safety standards.
8. Manage the QA team and promote a culture of excellence.
9. Proactively manage processes to ensure product and service quality.
10. Act as Management Representative for the QMS.
11. Manage the maintenance of the QMS to ISO13485 and FDA requirements.
12. Coordinate FDA facility inspections, notified body audits, and other audits and inspections.
13. Establish infrastructure to assure quality and collaborate with relevant teams to ensure performance improvement.
14. Ensure the effective functioning of design controls to ensure product quality.
15. Represent the quality department in NPI/NPD activities to ensure new products meet international quality and regulatory requirements.
16. Handle medical complaints reporting and filing to competent authorities.
17. Regularly review and manage change control processes to ensure they remain effective and efficient.
18. Ensure products are cleared to target markets according to the Regulatory plan.
19. Provide Regulatory Affairs support to internal and external customers.
20. Keep stakeholders informed of changing regulatory and compliance requirements.
21. Empower the Quality team to deliver departmental objectives and assist other departments in complying with quality requirements.
22. Collect and analyze data for monthly meetings and management review.
Requirements and Qualifications
To be successful in this role, you will need:
* A University Degree or Post-Graduate qualification, preferably in Quality Assurance.
* At least 8 years of experience in Medical Devices or a similar regulated industry.
* Significant regulatory affairs experience, including knowledge of international regulatory processes.
* Knowledge of product certification testing requirements for Medical Devices.
* In-depth knowledge of maintaining a certified QMS.
* 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 status.
* Awareness of quality assurance processes.
* High level of attention to detail.
* Proven leadership and communication skills.
* Results-oriented and self-motivated with the ability to work independently.
* Knowledge of and commitment to continuous improvement and problem-solving.
* Promote best practice and knowledge of QSR and ISO standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.
Benefits
This role offers a unique opportunity to develop your skills and expertise in quality management. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.