Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Bristol seeks a Quality Assurance Engineer focused on ensuring product compliance and customer expectations. The role includes developing the Quality Management System, conducting audits, and guiding manufacturing processes. Ideal candidates will have a relevant degree and experience with quality systems, specifically ISO 13485 and CAPA standards.

Qualifications

• Proven experience in Quality Systems and their implementation.
• Knowledge and practical experience with ISO 13485, CAPA, GDP, and GMP standards.

Responsibilities

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

Skills

Quality Systems

ISO 13485

Regulatory Compliance

Internal Audits

Supplier Quality

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, Bristol

Client:

Hyper Recruitment Solutions

Location:

Bristol, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

1

Posted:

06.06.2025

Expiry Date:

21.07.2025

Job Description:

Role Overview:

We are seeking a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. The role involves ensuring products and services are fit for purpose, compliant with regulations, and meet customer expectations.

Key Duties and Responsibilities:

1. Support development of the site Quality Management System (QMS) to meet business needs.
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:

Candidates should have:

1. A relevant degree in a scientific or engineering discipline.
2. Proven experience in Quality Systems and their implementation.
3. 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 candidates. HRS specializes in supporting the Life Science sectors, combining recruitment expertise with scientific knowledge to help advance your career.