Quality Assurance Engineer - Med Device

JR United Kingdom; Cardiff; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading medical device company in Cardiff is seeking a Quality Assurance Engineer to ensure products are compliant and meet customer expectations. Responsibilities include supporting the Quality Management System, conducting internal audits, and providing guidance on quality matters. This role requires a relevant degree and experience in quality systems.

Qualifications

• Experience with Quality Systems and their operational implementation.
• Knowledge of ISO 13485, CAPA, GDP, and GMP.

Responsibilities

• Support the development of the site's Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for audits.

Skills

Quality Systems

ISO 13485

CAPA

GMP

Regulatory Compliance

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Cardiff

Client: Hyper Recruitment Solutions

Location: Cardiff, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views:

1

Posted:

06.06.2025

Expiry Date:

21.07.2025

Job Description:

Role Overview:

We are seeking a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. The role involves ensuring products and services are fit for purpose, legally compliant, and meet customer expectations.

Key Duties and Responsibilities:

• Support the development of the site Quality Management System (QMS) to meet business requirements.
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for customer, regulatory, and notified body audits.
• Provide guidance on non-conformances and support manufacturing operations.

Role Requirements:

• Relevant degree in a scientific or engineering discipline.
• Experience with Quality Systems and their operational implementation.
• Knowledge and practical experience with ISO 13485, CAPA, GDP, and GMP.

Keywords: Quality Assurance Engineer, Quality Systems, ISO 13485, CAPA, GDP, GMP, Quality Management System, Medical Devices, Regulatory Compliance, Internal Audits, Supplier Quality

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help advance your career.