A superb career opportunity for a Quality Assurance Engineer has been created at an exciting Oxford based microfluidic ‘lab-on-chip’ technology company, set to revolutionise the life science, healthcare and biotech sectors. The Quality Engineer, whose QA experience could be from a variety of backgrounds, will assist in the development and ongoing management of the company’s formal Quality Management System, including creation of all procedures and policies from a blank sheet. This is a dynamic role which will see you make a real impact on the business as it grows from strength to strength. Candidates should be skilled with QMS, including the implementation within a highly regulated environment such as Medical, Aerospace, Automotive, Food, Pharma, etc.
Quality Engineer responsibilities include:
Assisting in the creation and update of standard operating procedures (SOPs) & Work Instructions
Leading training of internal users in relation to key SOPs
Conducting regular internal and external (supplier) audits against relevant standards and regulations;
Review, manage and maintain quality system documentation including non-conformance and CAPA tracking log
Maintenance and upkeep of electronic document control system for product design history and risk management
Assisting with risk assessments and product validation (hardware and software)
Active promotion of the quality driven culture internally and externally.
Demonstrable experience working in a QA/Quality Management role within a highly regulated environment.
Ideally, qualified to degree level in a technical subject, preferably Computer Science, Engineering, Natural Sciences -or equivalent combination of education and experience
A high level of initiative with ability to self-manage in a fast-paced environment
Computer literate with excellent written and verbal communication skills.
Ideally, some experience of ISO13485, IEC62304, ISO14971 and/or FDA GMP regulatory processes wou