Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Chelmsford is seeking a Quality Assurance Engineer. This role is critical for ensuring that products and services comply with regulatory requirements and meet customer expectations. The successful candidate will develop the Quality Management System and conduct audits while providing guidance during manufacturing operations.

Qualifications

• Proven industry experience in Quality Systems and operational implementation.
• Practical knowledge of ISO 13485, CAPA, GDP, and GMP.

Responsibilities

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

Skills

Quality Systems

ISO 13485

CAPA

GMP

Regulatory Compliance

Education

Relevant degree in scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Chelmsford

Client: Hyper Recruitment Solutions

Location: Chelmsford

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 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:

• Support the 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 day-to-day manufacturing operations.

Role Requirements:

To be successful in this role, candidates should have:

• A relevant degree in a scientific or engineering discipline.
• Proven industry experience in Quality Systems and their operational implementation.
• Practical knowledge of 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 exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.