Quality Assurance Engineer - Med Device

JR United Kingdom; Basingstoke; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading medical device company in Basingstoke is looking for a Quality Assurance Engineer. The role involves ensuring compliance with quality standards, supporting the development of the Quality Management System, and conducting internal audits. Candidates should have a relevant degree and experience in quality systems implementation, alongside practical knowledge of ISO 13485, CAPA, and GMP standards.

Qualifications

• Experience with 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 reports.
• Assist in preparations for customer and regulatory audits.

Skills

Detail Orientation

Analytical Skills

Problem Solving

Communication

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 in the SEERS Medical area. The successful candidate will ensure products and services are compliant, fit for purpose, and meet customer expectations.

Key Duties and Responsibilities:

1. Support the development of the site Quality Management System (QMS) to meet 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 manufacturing operations.

Role Requirements:

1. Relevant degree in a scientific or engineering discipline.
2. Experience with Quality Systems and their implementation in industry.
3. 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 all qualified candidates. HRS specializes in supporting the Life Science sectors with recruitment and scientific expertise.