Full job descriptionOwen Daniels are supporting a well-established manufacturing business operating within a highly regulated environment, is seeking an experienced Interim Quality Practitioner to support a critical quality improvement programme ahead of an upcoming ISO 13485 certification audit.

This is an excellent opportunity for an experienced quality professional with a strong background in a regulated manufacturing to make an immediate impact within a fast-paced environment.
The Role

Reporting into the Quality Leadership Team, you will be responsible for reviewing and strengthening the Quality Management System to ensure the business is fully prepared for external audit.

Key responsibilities will include:
*Reviewing and improving the Change Management process.
*Conducting a comprehensive gap analysis against ISO 13485 requirements and implementing corrective actions.
*Planning, conducting and reporting on internal audits.
*Ensuring quality documentation, procedures and records are fully compliant and audit ready.
*Driving corrective and preventive actions (CAPA) and continuous improvement activities.
*Providing coaching, guidance and training to cross-functional teams on quality processes and ISO 13485 requirements.
*Working collaboratively with operational and engineering teams to embed quality best practice across the business.
About You

To be considered for this opportunity, you will have:
*Proven experience working within an ISO 13485-certified environment (essential).
*Experience preparing organisations for external certification or surveillance audits.
*A strong background in leading internal audits and managing audit programmes.
*Experience reviewing and improving Quality Management Systems.
*Knowledge of change management within a regulated manufacturing environment.
*Excellent stakeholder management skills with the ability to influence teams at all levels.
*Strong problem-solving skills and a hands-on approach to delivering quality improvements.
*The ability to start at short notice and commit to a 3–6 month interim assignment.
Desirable*Lead Auditor qualification.
*Experience within regulated industries.
*Knowledge of CAPA, risk management and continuous improvement methodologies.
What’s on Offer*Immediate start on a high-profile interim assignment.
*Opportunity to play a key role in a business-critical audit preparation programme.
*Competitive day rate.
*3–6 month contract with potential for extension.
*Full-time, 100% on-site role based in Weymouth.
If you have proven ISO 13485 experience and are available for your next interim assignment, we’d love to hear from you. Apply today with your latest CV for immediate consideration.