Quality Engineer
We are seeking a Quality Engineer to join our team at a well-known global brand in the medical device sector. As a Quality Engineer, you will play a key role in supporting the development and implementation of an effective Quality Management System.
Key Responsibilities:
* Develop, implement, and oversee an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance.
* Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
Key Duties:
* Document control and review/approval of controlled documents
* Change management and review of change controls
* Investigation and CAPA management, including robust root cause analysis
* Complaint management and performance of complaint investigations
* Supplier quality management and performance of supplier audits as appropriate
* Internal audit program and performance of internal audits
* Training program; conduct training when needed
* Implementation of Quality Risk Management in relevant aspects of the QMS
* Management Review
* ISO certification and maintenance
Desired Experience:
* Ability to think clearly and act decisively when faced with challenges
* Ability to challenge and influence at all levels of the organisation to improve in an environment when standards are already very high