Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Cambridge is seeking a Quality Assurance Engineer to ensure compliance with regulations and customer expectations. The role includes maintaining the Quality Management System and conducting audits, requiring a relevant degree and experience with Quality Systems.

Qualifications

• Degree in a scientific or engineering discipline.
• Experience with Quality Systems in industry.
• Knowledge of ISO 13485, CAPA, GDP, and GMP standards.

Responsibilities

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

Skills

Quality Systems

ISO 13485

CAPA

GDP

GMP

Education

Relevant degree in scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Cambridge

Client: Hyper Recruitment Solutions

Location: Cambridge

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 the development and maintenance of the site Quality Management System (QMS).
• 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 with Quality Systems and their implementation in industry.
• 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 the Life Science sector, combining recruitment expertise with scientific knowledge to support your career development.