Description
The key responsibilities of the role include maintaining assigned areas to the requirements of ISO 13485 and the FDA 21 CFR Part 820, as well as maintaining the compliance of the product to the Medical Device Directive.Areas of responsibility may include but are not limited to CAPA, Internal Audits, Microbial controls, Non-Conforming Product review and disposition, Change Control, Complaints, Risk Management, and management of corrective actions.
The candidate will also be responsible for analysis and reporting of quality data, identifying and leading/supporting projects to deliver on Process Improvements which will deliver an improvement to quality, efficiency, and reduce costs. This will be complemented by strong technical aptitude with good organizational, communication, influencing, analytical, and excellent problem solving skills.
Responsibilities include maintaining records in accordance with the quality system requirements to meet the requirements of end users, customers, regulatory authorities and the company. It may also specifically include review of batch records, approval to release product and monitoring of in process and final product and process data and trends.
The successful candidate should have primary degree in Quality Management, Engineering, or Science, with a minimum of 3 years of medical device/pharmaceutical/diagnostics experience, preferably in a dynamic manufacturing environment. Strong, structured problem solving ability, 6 sigma and experience in a medical device assembly environment would be a distinct advantage.
If you would are interested in this opportunity and would like to apply for this position please contact Sarah Irvine on .