Quality Compliance Engineer – ISO 13485 Audits & CAPA

Avd Appoint Ltd; Gorseinon; On-site; GBP 24,000 - 40,000; Full time

Benefits offered by this job

Relocation

Benefits

Job summary

Avd Appoint Ltd is seeking a Quality Compliance Engineer for a role based in Glamorgan. The position involves performing ISO 13485 audits (internal and external), maintaining audit schedules, and guiding CAPA actions to drive continual improvement.

With a salary up to £40,000, relocation assistance and benefits are available. The role emphasises governance in a growing technology company operating in a highly regulated environment.

Qualifications

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

Responsibilities

• Lead internal audits in line with ISO 13485, ~60% of time.
• Host external audits for customers or certification bodies, ~30% of time.
• Create NCRs and perform root cause analysis (RCA) with CAPA actions.

Skills

Audits

ISO 13485

CAPA

NCRs

Tools

QMS

Job description

Avd Appoint Ltd is seeking a Quality Compliance Engineer for a role based in Glamorgan. The position involves performing ISO 13485 audits (internal and external), maintaining audit schedules, and guiding CAPA actions to drive continual improvement.

With a salary up to £40,000, relocation assistance and benefits are available. The role emphasises governance in a growing technology company operating in a highly regulated environment.