Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Basildon is seeking a Quality Assurance Engineer to ensure compliance with regulations and customer expectations. The role includes developing Quality Management Systems, conducting audits, and providing guidance on quality issues. Suitable candidates should have a relevant degree and proven experience in quality systems.

Qualifications

• Experience in implementing Quality Systems in the medical device industry.
• Knowledge of ISO 13485, CAPA, GDP, and GMP is essential.

Responsibilities

• Support the development of the site Quality Management System.
• Conduct internal quality audits and prepare audit reports.
• Assist in preparation for regulatory audits.

Skills

Quality Systems

Regulatory Compliance

Internal Audits

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Basildon

Client: Hyper Recruitment Solutions

Location: Basildon, 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, 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.
• 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.
• Proven industry experience in Quality Systems and their implementation.
• Knowledge and practical 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.