Job Title: Quality Engineer
About the Role:
Responsibilities:
* Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods.
* Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.
* Develop and execute product quality control plans, documents, and procedures.
* Provide input to risk analyses and Process Failure Mode Effect Analysis (pFMEAs) including with suppliers.
* Implement and enhance quality principles, gather and analyse quality data to support product/process improvement activities.
* Oversee manufacturing-related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations.
* Disposition non-conforming material and work with manufacturers and suppliers to implement corrective and preventive actions.
* Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
* Provide quality input into process validation activities.
Requirements:
* Bachelor's or Master's Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
* At least three years Quality Engineering experience or related role within the medical device industry.
* Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.