An exciting opportunity has arisen within this leading global manufacturer of medical devices for a Quality Systems Engineer to join its team based in Dundee.

THE ROLE

The role of the Quality Systems Engineer will report into the Quality Manager and be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS). Responsibilities include:

• Plan and conduct internal quality audits (EN ISO 13485:2016) in accordance with the audit schedule and company procedures and work instructions (QA-SOP-019 – Quality and Environmental Audit Management), ensuring all applicable regulatory requirements are met.
• Ensure follow up activities conducted include verification of actions taken and reporting of verification results
• Identify, record & investigate nonconformities / potential nonconformities in accordance with QA-SOP-018 Corrective and Preventive Action and associated work instructions.
• Identify and implement process improvements in conjunction with Line Managers / Process Owners to ensure processes required for the QMS meet the requirements of relevant ISO standards and applicable regulatory requirements.

THE PERSON

In order to succeed in the role of Quality Systems Engineer you will require experience of working within a Medical environment with exposure to ISO13485. Ideally you will be degree qualified in an engineering or medical subject. You will need to have good systems experience with strong regulations knowledge.

THE PACKAGE

• £45,000-£52,000 - Basic Salary
• Pension
• Life Assurance
• Medical Cover
• Excellent Holidays
• Training and Development