Quality Assurance Engineer - Med Device

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

Job summary

A leading medical device company in Colchester is seeking a Quality Assurance Engineer to develop and maintain its Quality Management System. The role involves conducting audits, supporting compliance with regulations, and ensuring products meet customer standards. Candidates should possess a relevant degree and experience in Quality Systems, particularly with ISO 13485 and related standards.

Qualifications

• Proven experience in Quality Systems and their operational implementation.
• Knowledge and practical experience with 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 preparation for customer, regulatory, and notified body audits.

Skills

Quality Systems

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, Colchester

Client:

Hyper Recruitment Solutions

Location:

Colchester, 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 successful candidate will ensure that 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:

To qualify for this role, candidates should have:

1. A relevant degree in a scientific or engineering discipline.
2. Proven experience in Quality Systems and their operational 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 individuals. HRS specializes in the Life Science sectors, combining recruitment expertise with scientific knowledge to support your career advancement.