Senior Quality Systems Engineer
We are seeking an experienced Senior Quality Systems Engineer to play a key role in the implementation and maintenance of our Quality Management System.
Job Description:
As a Senior Quality Systems Engineer, you will be responsible for ensuring our Veryan Quality Systems are compliant with relevant regulations, including the Medical Device Directive, FDA Quality System Regulations, ISO 13485, and ISO 14971. You will also maintain and continuously improve our quality management systems, act as Coordinator for CAPA, Complaints & Temporary Authorization processes, review and approval of Non-conformance reports, and manage Quality Systems data collection and analysis.
Responsibilities:
1. Ensure compliance with relevant regulations, including the Medical Device Directive, FDA Quality System Regulations, ISO 13485, and ISO 14971.
2. Maintenance and continuous improvement of the quality management systems.
3. Act as Coordinator for CAPA, Complaints & Temporary Authorization processes to support owners in meeting required timelines.
4. Review and approval of Non-conformance, CAPA, and Complaint investigation reports.
5. Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data, etc.
Requirements:
* Minimum Diploma Level education in Engineering, Science, or Quality Assurance discipline.
* Training/Qualification in Quality Systems, Complaints, and CAPA is highly desirable.
* A minimum of five years relevant experience in the medical device industry.
* Familiarity of ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
* Experience in management of Quality Systems activities, particularly Complaints and CAPA, is desirable.
Benefits:
We offer a competitive salary, bonus, pension, healthcare, and hybrid working environment.