Quality Assurance Specialist

Cure Talent Ltd; Greater London; Hybrid; GBP 42,000 - 64,000; Full time

Job summary

Cure Talent Ltd. is seeking a pragmatic QA Specialist for a 6-month fixed-term contract in London with hybrid working. The role focuses on supporting quality and regulatory processes across software and hardware products within a growing healthcare technology environment.

You will manage documentation, CAPA, change control and internal audits, contributing to a robust QMS and faster, more reliable decision-making as the business scales.

Qualifications

• Experience in quality assurance within medical devices or medical technology.
• Working knowledge of ISO 13485, EU MDR, FDA QSR / 21 CFR Part 820 and EN 62304.
• Experience with QMS processes, document control, SOPs, nonconformances, CAPA, change control and internal audits.
• Experience supporting regulated software and hardware products.
• Strong organisation, communication skills and a pragmatic approach.

Responsibilities

• Maintain and improve the quality management system and workflows.
• Review processes to identify gaps and opportunities for improvement.
• Govern quality activities including nonconformances, CAPA, change control, internal audits and quality metrics.
• Generate, review and revise SOPs, technical documentation and associated quality records.
• Collaborate cross-functionally to ensure compliance for software and hardware products as the business grows.

Skills

Quality Assurance

QMS Processes

Documentation Control

SOPs

CAPA

Change Control

Internal Audits

ISO 13485

Regulated Software

Attention to Detail

Communication Skills

Job description

Company Overview

We are delighted to be partnered with a growing healthcare technology company focused on improving ear and hearing health. Its integrated platform supports ear and hearing assessment, diagnosis and treatment within a single appointment, complemented by a training programme that helps practitioners deliver confident, effective care. As the business continues to expand, it is seeking a QA Specialist to join its team on a six-month fixed-term contract, based in London with hybrid working.

Position Overview

The QA Specialist will support the development and continuous improvement of quality and regulatory processes across software and hardware-related products. The role will help strengthen the quality management system, improve process consistency and support faster, more effective decision-making as the organisation scales.

Working cross-functionally, the successful candidate will manage and improve quality activities including document control, SOPs, nonconformances, CAPA, change control and internal audits. They will also review existing processes, identify opportunities for improvement, maintain quality records and contribute to technical documentation. This is an opportunity to make a visible contribution within a collaborative, fast-paced healthcare technology environment.

In practice, the team is looking for someone who can provide hands-on support to help close existing quality gaps, reduce the backlog of open findings and improve delivery speed. Experience working with legacy technology, an evolving QMS setup such as Qualia or a comparable system, and a pragmatic approach to quicker decision-making would all be valuable.

About the Ideal Candidate

The ideal candidate will be a pragmatic and detail-oriented quality professional with experience in medical devices or medical technology. They will be confident supporting regulated software and hardware products, improving quality systems and collaborating across teams. Strong organisation, communication skills and a systematic approach will be important.

Role Responsibilities

• Support the maintenance and continuous improvement of the quality management system, including the optimisation of workflows and quality processes.
• Review existing processes to identify gaps, inefficiencies and practical opportunities for improvement.
• Govern quality activities including nonconformances, CAPA, change control, internal audits and quality metrics.
• Generate, review and revise SOPs, technical documentation and associated quality records.
• Work cross-functionally to support compliance across software and hardware products, embedding consistent and sustainable quality practices as the business grows.

Key Requirements / What We Look For

• Experience in quality assurance, quality operations or quality systems within medical devices or medical technology.
• Working knowledge of ISO 13485, EU MDR, FDA QSR / 21 CFR Part 820 and EN 62304.
• Experience with QMS processes, document control, SOPs, nonconformances, CAPA, change control and in... internal audits.
• Experience supporting regulated software and hardware products.
• Strong organisation, attention to detail, communication skills and a pragmatic approach …