Senior Quality Assurance Engineer

Description:

A leading medical device business is seeking a highly skilled Senior Quality Assurance Engineer to join their expanding team. Based in the West Lothian area, this position plays a critical role within the Quality Assurance team as the company scales its operations globally. With upcoming product approvals in the US and significant growth planned for 2025, this is a pivotal moment for the business.

In this high-responsibility role, you will be working closely with the Head of Engineering, overseeing key aspects of the Quality Management System (QMS), batch release processes, and ensuring compliance with industry standards at all levels of the business. You will also be involved in internal audits, customer complaint management, post-market surveillance, and various quality improvement initiatives.

Further responsibilities include overseeing the Material Review Board, managing regulatory compliance projects, providing expert guidance on continuous improvement projects, and supporting management during notified body audits.

To succeed in this role, you should bring a wealth of experience in QA within medical devices or similar industries, a strong background in problem-solving, and the ability to manage stakeholder relationships across different organizational levels.