Quality Engineer - ISO 13485, CAPA & QMS

Hawk 3 Talent Solutions; Hardwicke; On-site; GBP 30,000 - 50,000; Full time

Benefits offered by this job

25 days annual leave

Company pension scheme

Enhanced maternity and paternity pay

Life assurance

Cycle to Work scheme

Free on-site parking

Employee Assistance Programme (EAP)

Perkbox benefits platform

Long service awards

Ongoing training and careerdevelopment

Occupational health support

Social and engagement events

Job summary

Hawk 3 Talent Solutions has partnered with a Gloucester-based manufacturer to recruit an experienced Quality Engineer. The role supports ongoing development of the Quality Management System in line with ISO 13485 and regulatory requirements, with emphasis on robust internal audits and improvement initiatives.

You will work across Manufacturing, Engineering and supply chain to ensure quality and compliance, drive CAPA actions, non-conformances and data-driven improvements, and contribute to

Qualifications

• Minimum 5 years' experience in a Quality Engineering/QA role in manufacturing.
• Strong working knowledge of ISO 13485:2016.
• Experience with CAPA, non-conformance, root-cause analysis and change control.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Plan and conduct ISO 13485 internal audits; support external audits.
• Manage CAPAs, non-conformances, root cause investigations and change control.
• Support supplier quality, validation activities and complaint investigations.
• Analyse quality data to identify trends and drive continuous improvement.
• Collaborate with Manufacturing, Engineering and cross-functional teams to ensure quality and compliance.

Skills

Quality auditing

CAPA management

Root cause analysis

Change control

Education

ISO 13485 internal auditor certification

Job description

Hawk 3 Talent Solutions has partnered with a Gloucester-based manufacturer to recruit an experienced Quality Engineer. The role supports ongoing development of the Quality Management System in line with ISO 13485 and regulatory requirements, with emphasis on robust internal audits and improvement initiatives.

You will work across Manufacturing, Engineering and supply chain to ensure quality and compliance, drive CAPA actions, non-conformances and data-driven improvements, and contribute to