Quality Assurance Expert

1 week ago


Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time
Company Overview: 52North - creators of Neutrocheck ® is a pioneering med-tech company that has been crowned 'MedTech Company of the Year' in the Cambridge Independent Science and Technology Awards. We're dedicated to revolutionising patient experiences and setting new industry standards through our innovative technology and human-centred approach.

We are at an exciting stage of growth, and we're looking for a Quality Specialist to join our collaborative and interdisciplinary team to manage our Quality Management System (QMS) on a day-to-day basis and support regulatory activities.

Salary: £55,000 - £65,000 per annum depending on experience

Job Description:
As a Quality Specialist, you will be responsible for delivering on company quality objectives, administering all aspects of the QMS, leading on internal and external audits, leading on quality activities, monitoring QMS performance, and identifying and implementing improvements.

You will also support the preparation of technical and design history files for our products by contributing to product technical and quality documentation and supporting the regulatory team with regulatory activities.

Required Skills and Qualifications:
- Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline
- At least 3 years' experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities
- Excellent attention to detail, organisational, team-working and communication skills

Benefits:
At 52North, we believe in taking care of our team's well-being and provide a range of benefits including flexible working, generous holiday allowance, maternity and paternity leave policies, EMI share option scheme, pension scheme, health insurance, dental and optical coverage, wellbeing engagement programme, social activities, and office perks.

Others:
The ideal candidate will have excellent problem-solving skills, be proactive and able to work collaboratively in a small, fast-paced and interdisciplinary team. If you're passionate about ensuring quality for state-of-the-art technology to make healthcare systems more efficient and transform the lives of patients around the world, apply now.

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