Quality Compliance Engineer | ISO 13485 Audits | Relocation

AVD Appoint Ltd; Swansea; On-site; GBP 24,000 - 40,000; Full time

Job summary

AVD Appoint Ltd in Glamorgan is seeking a Quality Compliance Engineer to join a growing team specialising in highly regulated design, development and manufacture of advanced products. The role focuses on ensuring adherence to ISO 13485 and maintaining audit readiness.

You will lead internal audits (60%), host external audits for customers and cert bodies (30%), and drive CAPA actions through root cause analysis to support continual improvement.

Qualifications

• Previous experience as a Quality Compliance Engineer or similar.
• At least 3 years' experience conducting audits in a highly regulated environment.
• Experience with ISO:13485.

Responsibilities

• Conduct internal audits in line with ISO 13485, occupying ~60% of time and coordinating audit schedules.
• Host external audits for customers or certification bodies, occupying ~30% of time.
• Prepare non-conformance reports (NCRs) and perform root cause analysis (RCA) with corrective and preventive actions (CAPAs).

Skills

Quality Compliance

Auditing

Regulatory Knowledge

Job description

AVD Appoint Ltd in Glamorgan is seeking a Quality Compliance Engineer to join a growing team specialising in highly regulated design, development and manufacture of advanced products. The role focuses on ensuring adherence to ISO 13485 and maintaining audit readiness.

You will lead internal audits (60%), host external audits for customers and cert bodies (30%), and drive CAPA actions through root cause analysis to support continual improvement.