We are expanding our team and are recruiting a Quality Systems Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification.
As a Quality Systems Engineer, you will:
Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System with activities including document control, training management and change management.
Draft and update procedures, work instructions, and quality documentation.
Collaborate closely with Engineering (Software and Hardware) and Customer Support teams to investigate and identify root causes of quality-related issues from customer complaints, internal non-conformances and audit findings.
Assist with the implementation of CAPAs and closure of non-conformances.
Collaborate with cross-functional teams on documentation creation, risk management, and validation activities.
Support quality compliance for SaMD products, including lifecycle and version control.
Participate in internal and external audits.
Analyse quality data and contribute to process improvement initiatives.
Required experience:
2+ years of experience in a Quality role within the medical device industry
Hands-on knowledge of ISO 13485 and 21 CFR 820
Strong attention to detail and problem solving skills
Ability to work as part of a multi-disciplinary, fast-paced diverse team
Ability to work independently and prioritise tasks
Excellent communication, interpersonal, organisational and IT skills
Helpful experience:
Experience with electronic Quality Management Systems (eQMS)
Exposure to software as a medical device / IEC 62304
Technical/procedural writing experience
Familiarity with medical device regulatory requirements in the UK, EU, or US
Experience in an electronics-related medical device manufacturing environment would be advantageous
Minimum Qualifications:
A Bachelor’s or Master’s degree in a Life Science, Engineering, or a related field
Salary & Benefits:
Competitive salary and performance-based bonus scheme
Competitive benefits including pension match and private medical insurance
Work with an awesome team of smart and motivated people on cool and unique technology that can positively impact the lives of millions of people
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