Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company is seeking a Quality Assurance Engineer to ensure product and service integrity. Responsibilities include developing the Quality Management System, conducting audits, and ensuring compliance with industry standards such as ISO 13485. The ideal candidate will possess a relevant scientific or engineering degree and practical experience in Quality Systems.

Qualifications

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

Responsibilities

• Support the development of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Assist in preparations for customer, regulatory, and notified body audits.

Skills

Quality Systems

ISO 13485

CAPA

GDP

GMP

Regulatory Compliance

Education

Relevant degree in a scientific or engineering discipline

Job description

Role Overview

We are seeking a Quality Assurance Engineer to join a leading medical device company located in the SEERS Medical area. The successful candidate will ensure that products and services are fit for purpose, compliant with legal standards, and meet customer expectations.

Key Duties and Responsibilities:

1. Support the development of the site Quality Management System (QMS) to align with business needs.
2. Conduct internal quality audits and prepare audit reports.
3. Assist in preparations for customer, regulatory, and notified body audits.
4. Provide guidance on non-conformances and support daily manufacturing operations.

Role Requirements:

• Relevant degree in a scientific or engineering discipline.
• Proven experience in Quality Systems and their implementation in industry.
• Practical 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 candidates who meet the role requirements. HRS specializes in supporting the Life Science sectors with recruitment expertise and scientific knowledge to help advance your career.