QA Engineer - ISO 13485, CAPA & Audits

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

Benefits offered by this job

25 days holiday

Company pension

Enhanced maternity/paternity pay

Life assurance

Cycle to work

Free on-site parking

Employee Assistance Programme (EAP)

Perkbox benefits platform

Long service awards

Ongoing training and career dev

Job summary

Hawk 3 Talent Solutions is recruiting for a Gloucester-based manufacturer to hire an experienced Quality Engineer to drive the Quality Management System in line with ISO 13485 and regulatory requirements.

Responsibilities include maintaining the QMS, planning ISO 13485 internal audits, supporting external audits, managing CAPAs and non-conformances, root cause investigations and change control, and supporting supplier quality.

Qualifications

• Minimum 5 years' experience in Quality Engineering/QA within manufacturing.
• Strong knowledge of ISO 13485:2016.
• Experienced with CAPA, non-conformance management, root cause analysis 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.
• Analyse quality data to identify trends and drive continuous improvement initiatives.
• Collaborate with Manufacturing, Engineering and cross-functional teams to ensure quality and compliance.

Skills

Quality engineering

ISO 13485

Auditing

CAPA handling

Root cause analysis

Education

ISO 13485 Internal Auditor

Job description

Hawk 3 Talent Solutions is recruiting for a Gloucester-based manufacturer to hire an experienced Quality Engineer to drive the Quality Management System in line with ISO 13485 and regulatory requirements.

Responsibilities include maintaining the QMS, planning ISO 13485 internal audits, supporting external audits, managing CAPAs and non-conformances, root cause investigations and change control, and supporting supplier quality.