Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company seeks a Quality Assurance Engineer in Warrington. This role involves ensuring products meet customer expectations and comply with legal standards. You'll support quality management systems, conduct audits, and provide guidance on non-conformances, working with regulatory bodies.

Qualifications

• Degree in a scientific or engineering discipline is required.
• Experience in Quality Systems and operational implementation is essential.
• Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards needed.

Responsibilities

• Support the development and maintenance of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for customer and regulatory 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, Warrington, Cheshire

Client: Hyper Recruitment Solutions

Location: Warrington, Cheshire

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 currently 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:

• Support the development and maintenance 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 in Quality Systems and their operational implementation.
• 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 candidates. HRS specializes in supporting the Life Science sectors with recruitment expertise and scientific knowledge to advance your career.