Global Quality Systems Engineer - Medical Devices & CAPA

Walker Cole International; West Yorkshire; On-site; GBP 60,000 - 80,000; Full time

Job summary

Walker Cole International partners with a Class III medical device manufacturer to recruit a Quality Systems Engineer who will lead the development, measurement and continual improvement of global QMS sub-processes. You will provide direct on-the-floor quality engineering support to production in compliance with ISO 13485 and 21 CFR 820.

You will drive KPI reporting, support CAPA/NCR processes, audits and training, ensuring robust documentation and risk-based decision-making across manufacturing

Qualifications

• Bachelor's degree in a quality-related field or equivalent experience in a regulated environment.
• Knowledge of 21 CFR 820, ISO 13485 and EU MDR is desirable.
• Experience with CAPA, NCR handling and MRB review is advantageous.

Responsibilities

• Own global QMS performance KPIs and metrics with data-driven leadership reporting.
• Lead NCRs, CAPA and quality plans for underperforming sub-processes.
• Ensure QMS documents are filed, scanned and retrievable as primary contact.
• Conduct audits (first/second party) and support third-party audits.
• Establish and deliver training on core QMS systems and procedures.

Skills

Quality systems

QMS metrics

Risk management

Auditing

Data analysis

Project management

On-floor support

Education

Bachelor's degree in related field

Job description

Walker Cole International partners with a Class III medical device manufacturer to recruit a Quality Systems Engineer who will lead the development, measurement and continual improvement of global QMS sub-processes. You will provide direct on-the-floor quality engineering support to production in compliance with ISO 13485 and 21 CFR 820.

You will drive KPI reporting, support CAPA/NCR processes, audits and training, ensuring robust documentation and risk-based decision-making across manufacturing