Senior Quality Assurance Engineer - QARA

PDQ Engineering Recruitment & Training Services Lt; Abingdon; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading engineering recruitment firm is seeking a Senior Quality Assurance Engineer to enhance their Quality Management System and ensure compliance with ISO 13485 and FDA regulations. This role involves acting as Deputy for the QARA Manager and working to maintain high standards of product safety and quality. Ideal candidates will have significant experience in regulatory requirements and previous assurance processes. Applicants must be eligible to work in the UK without sponsorship.

Qualifications

• Experience with ISO 13485 and FDA 21 CFR 820 compliance.
• Proven track record in quality assurance processes.

Responsibilities

• Act as Deputy for the QARA Manager for Quality Assurance matters.
• Maintain and improve the Quality Management System.
• Ensure compliance with national and international standards.
• Support the QARA Manager in monitoring compliance.

Job description

Overview

Senior Quality Assurance Engineer / Senior QARA Engineer / Senior Quality Engineer

Reporting to the QARA Manager, the Senior Quality Assurance Engineer supports the effective operation, maintenance, and continuous improvement of the Quality Management System. The role is responsible for ensuring organisational compliance with ISO 13485, FDA 21 CFR 820, and other applicable global quality and regulatory requirements. The Senior Quality Engineer ensures that all required company processes are properly established, implemented, and monitored for ongoing effectiveness, and provides technical quality leadership across the business to maintain high standards of product safety, quality, and regulatory conformity.

NOTE: This position is only open to British / EU / ILR Applicants and offers no sponsorship.

Main Tasks

• Quality and Regulatory: Act as Deputy for the QARA Manager for all matters relating to Quality Assurance.
• Maintain, develop, and improve the Quality Management System in alignment with ISO 13485, FDA 21 CFR 820, and other relevant global regulatory requirements.
• Ensure compliance with national and international standards and legislation.
• Maintain a suitable regulatory framework and associated processes and to update the quality and regulatory processes as necessary in line with new international or country specific legislation.
• Support the QARA Manager in monitoring and ensuring compliance with applicable quality and regulatory requirements.