Stem Recruitment have a fantastic opportunity for a Quality Engineer to work for an IVD company based near Edinburgh. This will be a hybrid role. This person will be responsible for the management of Complaints, Post Market Surveillance (PMS) and Product Risk Management for all their Products.
Responsibilities
*Ensure the complaint management process for all products is completed to a high standard in compliance with internal procedures and international standards.
*Through completion of the relevant Product Risk Management and Product Post Market Surveillance (PMS) activities, ensure that their products are maintained in compliance with all relevant Regulations.
*Manage risk throughout the entire Design Control Process for new projects and through Core QMS processes (such as Non-Conforming Product management, Change Management, Complaint Management) for on market products.
Requirements
Science degree or equivalent qualification, or a relevant degree combined with appropriate industry experience.
Experience in medical device/IVD/Biotech industry
Strong understanding of QMS processes, i.e. Customer Complaints, CAPA, change management
If this role is of interest, please get in touch.