Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Sheffield is seeking a Quality Assurance Engineer to ensure that all products comply with quality standards and meet customer expectations. The ideal candidate should have a relevant degree and expertise in quality systems, including ISO regulations. Key duties involve developing the Quality Management System, conducting audits, and providing guidance on non-conformances.

Qualifications

• Proven experience in Quality Systems and their operational implementation.
• 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 reports.
• Support preparation for customer and regulatory audits.

Skills

Quality Systems

ISO 13485

CAPA

GDP

GMP

Regulatory Compliance

Internal Audits

Supplier Quality

Education

Relevant degree in a scientific or engineering discipline

Job description

Quality Assurance Engineer - Med Device, Sheffield, South Yorkshire

Client: Hyper Recruitment Solutions

Location: Sheffield, South Yorkshire, 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 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 experience in Quality Systems and their operational implementation.
• Knowledge and practical experience with ISO 13485, CAPA, GDP, and GMP.

Key Words: 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.