Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company is looking for a Quality Assurance Engineer to ensure products and services meet regulations and customer expectations. The role involves supporting the development of the Quality Management System, conducting audits, and providing guidance on non-conformances. This position requires a relevant degree and knowledge of industry standards like ISO 13485 and GMP.

Qualifications

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

Responsibilities

• Support development of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Assist in preparing for customer, regulatory, and notified body audits.

Skills

Quality Systems

Regulatory Compliance

Auditing

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Luton, Bedfordshire

Client: Hyper Recruitment Solutions

Location: Luton, Bedfordshire, 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, compliant with regulations, and meet customer expectations.

Key Duties and Responsibilities:

• Support development of the site Quality Management System (QMS) to meet business needs.
• Conduct internal quality audits and prepare audit reports.
• Assist in preparing 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 implementation.
• 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 candidates. HRS specializes in supporting the Life Science sectors with recruitment expertise and scientific knowledge.