Quality Coordinator – ISO 13485 & CAPA Expert (On-site)

L-ev8 Recruitment Ltd; Burgess Hill; On-site; GBP 36,000 - 44,000; Full time

Job summary

L-ev8 Recruitment Ltd is handling an exciting Quality Coordinator role in West Sussex for a long-established packaging solutions provider serving the pharmaceutical, healthcare, biotech and diagnostics sectors. The role focuses on maintaining and improving the QMS, managing non-conformances, and supporting investigations and CAPA within ISO 9001 and ISO 13485 frameworks.

Reporting to the Head of Quality, you will coordinate quality processes, maintain essential records, and opportunities for

Qualifications

• Minimum 5 years' experience working within a QMS in a regulated industry.
• Experience with ISO 9001 and/or ISO 13485 environments.
• Experience managing Non-Conformance Reports (NCRs), investigations and Change Control processes.
• Strong document control experience, including maintaining SOPs, quality records and databases.
• Experience supporting CAPA processes, root cause investigations and corrective action effectiveness reviews.
• Knowledge of supplier qualification, monitoring and quality performance management.
• Experience supporting internal, supplier, customer and certification body audits would be advantageous.
• Experience within medical devices, pharmaceuticals, healthcare or regulated distribution would be beneficial.
• Strong organisational, analytical and communication skills, with the ability to manage priorities and work independently.
• Proficient in Microsoft Office applications.
• An Internal Auditor qualification and practical auditing experience would be advantageous.

Responsibilities

• Coordinate quality processes and maintain the QMS.
• Manage non-conformances and CAPA activities.
• Support investigations and corrective actions.
• Maintain ISO 9001 and ISO 13485 compliance.
• Assist in supplier qualification and performance monitoring.

Skills

QMS experience

ISO 9001/13485

NCRs & investigations

CAPA investigations

Documentation control

Supplier quality

Audits (internal/supplier/cert)

Regulated industry

Organisational skills

Microsoft Office

Internal Auditor qualification

Tools

Microsoft Office

Job description

L-ev8 Recruitment Ltd is handling an exciting Quality Coordinator role in West Sussex for a long-established packaging solutions provider serving the pharmaceutical, healthcare, biotech and diagnostics sectors. The role focuses on maintaining and improving the QMS, managing non-conformances, and supporting investigations and CAPA within ISO 9001 and ISO 13485 frameworks.

Reporting to the Head of Quality, you will coordinate quality processes, maintain essential records, and opportunities for