Quality Assurance Engineer - Med Device

JR United Kingdom; Aberdeen City; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading medical device company is seeking a Quality Assurance Engineer to ensure products meet compliance and customer expectations. The role involves supporting the Quality Management System, conducting audits, and providing guidance on quality standards. Ideal candidates will have a relevant scientific or engineering degree and experience with ISO standards.

Qualifications

• Relevant degree in a scientific or engineering discipline required.
• Experience with Quality Systems and their implementation in industry.
• Practical knowledge of ISO 13485, CAPA, GDP, and GMP standards.

Responsibilities

• Support development of site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Provide guidance on non-conformances and support manufacturing operations.

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

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 fit for purpose, legally compliant, and meet customer expectations.

Key Duties and Responsibilities:

1. Support the development of the site Quality Management System (QMS) to meet business requirements.
2. Conduct internal quality audits and prepare audit reports.
3. Assist in preparation 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 individuals. HRS specializes in supporting the Life Science sector, combining recruitment expertise with scientific knowledge to advance your career.