Selexa Life Sciences is supporting a leading Medical Device client in the search for a Quality Engineer to support quality assurance, product compliance and continuous improvement within a specialist medical device manufacturing environment.
Key Areas of Focus:
- Supplier Quality Management
- Distributor Qualification and Oversight
- NPD Quality Assurance
- Design Transfer QA
Key responsibilities:
- Maintain and improve Quality Management Systems (QMS)
- Knowledge of supplier qualification and SQA processes
- Understanding of design controls, risk management and product development processes
- Lead & support investigations relating to non-conformances, deviations and CAPAs
- Support change control activities and quality assurance assessments
- Support ISO 13485 compliance and regulatory requirements
- Manage non-conformances, CAPAs and root cause investigations
- Support internal audits, risk management and process improvements
- Work collaboratively with engineering, manufacturing and regulatory teams
The ideal candidate:
An experienced Quality Engineer with a background in medical devices, strong QMS knowledge and a proactive approach to quality and continuous improvement.
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