Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Newport is seeking a Quality Assurance Engineer to ensure compliance of products and services. The role involves developing the Quality Management System, conducting audits, and providing support on regulatory compliance. Ideal candidates will possess a relevant degree and experience with quality systems, including standards such as ISO 13485 and CAPA.

Qualifications

• Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards.
• Proven experience with Quality Systems and their implementation.

Responsibilities

• Support the development of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Provide guidance on non-conformances and support manufacturing operations.

Skills

Quality Systems

ISO 13485

CAPA

GMP

Regulatory Compliance

Education

Relevant degree in scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Newport

Client:

Hyper Recruitment Solutions

Location:

Newport, 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 successful candidate will ensure that products and services are fit for purpose, legally compliant, and meet customer expectations.

Key Duties and Responsibilities:

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

Role Requirements:

Ideal candidates will have:

1. A relevant degree in a scientific or engineering discipline.
2. Proven experience with Quality Systems and their implementation.
3. Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards.

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 all qualified individuals. HRS specializes in supporting the Life Science sector, combining recruitment expertise with scientific knowledge to help advance your career.