Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company is seeking a Quality Assurance Engineer in Norwich to develop QMS, conduct audits, and ensure compliance with standards like ISO 13485. The ideal candidate will have a relevant scientific or engineering degree and practical experience in quality systems.

Qualifications

• Degree in scientific/engineering discipline required.
• Experience with Quality Systems implementation is essential.
• Knowledge of ISO 13485, CAPA, GMP standards critical.

Responsibilities

• Develop and maintain the Quality Management System (QMS).
• Conduct internal quality audits and prepare reports.
• Assist in customer and regulatory audits.

Skills

Quality Systems

ISO 13485

CAPA

GMP

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 compliant, fit for purpose, and meet customer expectations.

Key Duties and Responsibilities:

1. Support the development and maintenance of the site Quality Management System (QMS) to align with business needs.
2. Conduct internal quality audits and prepare detailed audit reports.
3. Assist in preparing 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 an industrial setting.
3. Practical knowledge of ISO 13485, CAPA processes, 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.