Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company based in York is seeking a Quality Assurance Engineer to ensure products and services comply with quality standards and regulations. In this role, you will support the development of Quality Management Systems, conduct audits, and guide on non-conformances. The ideal candidate should have a relevant degree and experience in Quality Systems, particularly with ISO standards.

Qualifications

• Experience with ISO 13485, CAPA, GDP, and GMP.
• Proven experience in Quality Systems implementation.

Responsibilities

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

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, York

Client:

Hyper Recruitment Solutions

Location:

York

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

Key Duties and Responsibilities:

• Support development of the site Quality Management System (QMS) to meet business requirements.
• Conduct internal quality audits and prepare audit reports.
• Support 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.
• Proven experience in Quality Systems and their implementation.
• Knowledge and experience with ISO 13485, CAPA, GDP, and GMP.

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 anyone who meets the role requirements. HRS supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help advance your career.