Quality Engineer – South Wales – Medical Device
About the Company:
We are looking for a Quality Engineer from the Medical Device industry to work at an expanding company in south Wales. In this role you will provide quality support across manufacturing, sterilisation, packaging and the shipment of medical devices.
Responsibilities:
* Provide practical Quality Engineering expertise across diverse projects, applying solid engineering principles to support timely and effective project execution.
* Ensure effective implementation of Master Validation Plans to support site qualification and validation activities.
* Lead validation programs for processes, computerized systems, and cleaning, including the creation and independent review of protocols and reports using sound statistical methodologies, with a strong focus on data verification and statistical analysis.
* Lead investigations into complex product quality and compliance issues, identifying impact, root cause, and implementing corrective actions.
* Implement and verify the effectiveness of corrective and preventive actions (CAPAs).
* Manage product complaint handling in collaboration with Engineering and Operations teams.
* Provide hands-on support for general and technical quality issues to enable timely decision-making across the site.
* Mentor and coach Quality team members, with a focus on validation, investigations, and critical thinking.
* Support internal, supplier, and external audits (e.g., notified bodies).
* Address nonconformances for both internal and supplier-related product issues.
* Review Quality Management System (QMS) elements to ensure proper functionality and compliance.
* Conduct independent reviews of sterilization validation protocols and reports.
* Develop and independently review equipment qualifications and gauge R&R studies.
* Drive continuous improvement initiatives to streamline systems and procedures.
* Lead cross-functional teams in developing and maintaining risk management documentation, including process FMEAs and periodic reviews. Ensure risk management is embedded in the product lifecycle and continuous improvement processes.
* Support compliant use of equipment maintenance systems, including preventive maintenance and calibration.
* Perform additional responsibilities as assigned by Management.
Requirements:
* Degree in an engineering or scientific discipline.
* Experience working as a Quality Engineer in the medical device manufacturing industry.
* Excellent knowledge of ISO 13485 and ISO 14971.
* Experience of equipment qualifications and process validations.
* Experience managing non-conformances and deviations, including investigations, root cause, and CAPA.
* Experience leading risk management.
* Experience leading cross functional projects.
* Good knowledge of continuous improvement methodologies.
* Excellent communication skills.
* Experience in software validation and a knowledge of GAMP 5 would be advantageous.