Overview of the Role:
The Senior Quality Engineer will be responsible for maintaining and improving our quality management system, ensuring compliance with relevant regulations.
The role involves acting as a coordinator for CAPA, Complaints & Temporary Authorization processes, reviewing and approving non-conformance, CAPA, and Complaint investigation reports.
* Maintaining Veryan Quality Systems compliance
* Coordinating CAPA, Complaints & Temporary Authorization processes
Key Responsibilities:
- Maintain compliance with various regulations
- Act as Coordinator for CAPA, Complaints & Temporary Authorization processes
- Review and approve Non-conformance, CAPA, and Complaint investigation reports
Benefits:
- Salary package including hybrid working arrangement
- Bonus scheme
- Contributory pension plan
- Comprehensive healthcare benefits
Requirements:
- Minimum Diploma Level in Engineering, Science or Quality Assurance
- Five years experience in medical device industry
Familiarity with ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is essential. Experience in managing Quality Systems activities, particularly Complaints and CAPA, is desirable.