Key Quality Assurance Professional
We seek a skilled Quality Assurance Professional to join our team. The successful candidate will work closely with the quality and regulatory affairs teams to ensure the development and maintenance of quality systems that meet international standards.
Job Responsibilities:
1. Develop and maintain quality systems in accordance with ISO 13485:2016 and 21CFR Part820 regulations.
2. Manage document control processes to ensure consistency and compliance across all departments.
3. Represent quality functions at meetings and provide guidance to teams to support their objectives.
4. Participate in risk management activities to identify and mitigate risks in line with ISO 14971:2019 requirements.
5. Liaise with technical operations to ensure high-quality product delivery in compliance with procedures and regulations.
6. Prepare quality metrics for management meetings and reviews.
7. Address customer complaints in accordance with relevant regulations, ensuring vigilance and reporting requirements are met.
8. Manage CAPA system to address observations and non-conformances comprehensively.
9. Maintain computerised system validation in line with documented procedures and regulations.
10. Oversee internal audits to ensure timely completion and resolution of non-conformances.
11. Support supplier management to ensure compliance with quality system requirements.
12. Prepare reports and documents to support project success.
13. Promote continuous improvement of quality system processes and business practices.
Requirements:
* Bachelor's degree in Science or Engineering is essential.
* A minimum of eight years' experience in quality engineering or regulatory roles, preferably in the medical device industry.
* Excellent written, interpersonal, and presentation skills.
* A self-starter able to deliver work with minimal direction.
* Strong communication skills, including summarization and presentation.
* A solid understanding of team dynamics and ability to participate in high-performing teams.
* Able to prioritize critical objectives amidst numerous tasks and activities.
Contact Information:
For further information please contact us.