Quality Assurance Engineer - Med Device

JR United Kingdom; Derby; On-site; GBP 35,000 - 50,000; Full time

Job summary

Une entreprise leader dans le domaine des dispositifs médicaux recherche un ingénieur en assurance qualité basé à Derby. La mission consiste à garantir que les produits et services respectent les exigences légales et les attentes des clients. Le candidat retenu participera au développement du système de gestion de la qualité et réalisera des audits internes pour assurer la conformité.

Qualifications

• Expérience prouvée avec les systèmes de qualité et leur mise en œuvre.
• Connaissance pratique des normes ISO 13485, CAPA, GDP et GMP.

Responsibilities

• Soutenir le développement du système de gestion de la qualité du site.
• Conduire des audits internes et préparer des rapports d'audit.
• Assister à la préparation des audits clients et réglementaires.
• Fournir des conseils sur les non-conformités.

Skills

Quality Systems

ISO 13485

CAPA

GMP

Regulatory Compliance

Education

Relevant degree in a scientific or engineering discipline

Job description

Social network you want to login/join with:

Quality Assurance Engineer - Med Device, Derby

Client:

Hyper Recruitment Solutions

Location:

Derby, 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 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 preparation for customer, regulatory, and notified body audits.
4. Provide guidance on non-conformances and support manufacturing operations.

Role Requirements:

To succeed in this role, candidates should possess:

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 with recruitment expertise and scientific knowledge to advance careers.