Quality Assurance Engineer - Med Device

JR United Kingdom; Swindon; On-site; GBP 35,000 - 45,000; Full time

Job summary

Une entreprise leader dans le secteur des dispositifs médicaux recherche un Ingénieur Assurance Qualité basé à Swindon. Ce rôle implique de garantir la conformité aux réglementations, de soutenir le développement du système de gestion de qualité et de réaliser des audits internes. Le candidat idéal aura un diplôme pertinent en science ou ingénierie et une expérience pratique avec les exigences ISO et CAPA.

Qualifications

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

Responsibilities

• Supporter le développement du système de gestion de la qualité (QMS) du site.
• Réalisations d'audits internes et préparation de rapports d'audit.
• Fournir des orientations sur les non-conformités et appuyer les opérations de fabrication quotidien.

Skills

Quality Systems

Regulatory Compliance

Internal Audits

Supplier Quality

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, swindon, wiltshire

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Client:

Hyper Recruitment Solutions

Location:

swindon, wiltshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

1

Posted:

06.06.2025

Expiry Date:

21.07.2025

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Job Description:

ROLE OVERVIEW

We are currently looking for a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. As the Quality Assurance Engineer, you will be responsible for ensuring that products and services are fit for purpose, legally compliant, and meet customer expectations.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Assurance Engineer will be varied; however, the key duties and responsibilities are as follows:

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. Support preparation for customer, regulatory, and notified body audits.

4. Provide guidance on non-conformances and support day-to-day manufacturing operations.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Quality Assurance Engineer, we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or engineering discipline.

2. Proven industry experience in Quality Systems and their operational implementation.

3. A working knowledge and practical experience with ISO 13485, CAPA requirements, GDP, and GMP.

Key Words:

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 exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.