Quality Engineer – ISO 13485 & CAPA Expert

Hawk 3 Talent Solutions; Gloucester; On-site; GBP 45,000 - 55,000; Full time

Benefits offered by this job

Annual leave

Pension with salary sacrifice

Enhanced maternity/paternity pay

Life assurance

Cycle to Work

On-site parking

EAP

Perkbox discounts

Long service awards

Training and career development

Occupational health

Social events

Job summary

Hawk 3 Talent Solutions in Gloucester seeks an experienced Quality Engineer to support the ongoing development of the Quality Management System in line with ISO 13485 and regulatory requirements. The role covers internal auditing, CAPA management, supplier quality, validation and continuous improvement across cross-functional teams.

The successful candidate will have 5+ years in a manufacturing quality role, be an ISO 13485 Internal Auditor, and demonstrate strong analytical and communication

Qualifications

• Experience in a manufacturing environment with quality engineering/quality assurance roles.
• Strong knowledge of ISO 13485:2016 and internal auditing experience.
• Experience with CAPA, non-conformances, root cause investigations and change control.

Responsibilities

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

Skills

Quality assurance

CAPA

Root cause analysis

Change control

Continuous improvement

Internal auditing

QMS

Job description

Hawk 3 Talent Solutions in Gloucester seeks an experienced Quality Engineer to support the ongoing development of the Quality Management System in line with ISO 13485 and regulatory requirements. The role covers internal auditing, CAPA management, supplier quality, validation and continuous improvement across cross-functional teams.

The successful candidate will have 5+ years in a manufacturing quality role, be an ISO 13485 Internal Auditor, and demonstrate strong analytical and communication