Quality Engineer

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.

Requirements
• 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

Job Details

  • Job Ref: 11684
  • Salary: £35000 - £50000
  • Consultant Name: Adam Mayne
  •   Oxford Oxfordshire
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