Quality Assurance Engineer - Med Device

JR United Kingdom; Milton Keynes; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading medical device company is seeking a Quality Assurance Engineer in Milton Keynes. The role involves ensuring compliance and fitness for purpose, maintaining the Quality Management System, and conducting internal audits. Ideal candidates will have a relevant degree and experience with Quality Systems and ISO standards.

Qualifications

• Degree in a scientific or engineering discipline required.
• Experience with Quality Systems implementation in industry setting needed.
• Knowledge of ISO 13485, CAPA, GDP, and GMP standards necessary.

Responsibilities

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

Skills

Quality Systems

ISO 13485

CAPA

GDP

GMP

Education

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 that products and services are compliant, fit for purpose, and meet customer expectations.

Key Duties and Responsibilities:

• Support the development and maintenance of the site Quality Management System (QMS) to meet business needs.
• Conduct internal quality audits and prepare detailed audit reports.
• Assist in preparing for customer, regulatory, and notified body audits.
• Provide guidance on non-conformances and support manufacturing operations.

Role Requirements:

• Degree in a scientific or engineering discipline.
• Experience with Quality Systems and their implementation in an industry setting.
• Knowledge and practical experience with 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 individuals. HRS specializes in supporting the Life Science sector with recruitment expertise and scientific knowledge.