Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in the SEERS Medical area is looking for a Quality Assurance Engineer to join their team. The role involves ensuring products meet compliance standards and customer expectations, supporting the Quality Management System, conducting audits, and providing guidance on quality issues. This position is ideal for individuals with a scientific or engineering background and experience in quality systems.

Qualifications

• Experience with Quality Systems and their implementation in the 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.
• Provide guidance on non-conformances and support manufacturing operations.

Skills

Quality Systems

Regulatory Compliance

Internal Audits

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 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 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. Degree in a scientific or engineering discipline.
2. Experience with Quality Systems and their implementation in the 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 the Life Science sector, combining recruitment expertise with scientific knowledge to support your career development.