Business & Product Quality Lead
A leading multinational manufacturer is seeking an experienced Business & Product Quality Lead to oversee quality and compliance across their Europe & Africa operations. This is a senior, technical role with responsibility for ensuring regulatory compliance and high product standards across new product launches and product changes.
The Role
Reporting to the GMG CoE - Quality Head, you will act as the technical expert on quality standards and regulatory requirements, including MDD/MDR, MHRA, ISO 13485, and QSR. You will collaborate closely with commercial, R&D, regulatory, manufacturing, and operations teams to deliver on-time, high-quality product launches.
This is a role for someone who combines strategic thinking with hands-on quality expertise, influencing cross-functional teams and leading the development and maintenance of the local Quality Management System (QMS).
Key Responsibilities
* Provide oversight of the QMS for all business products and services, ensuring regulatory compliance and adherence to corporate quality policies.
* Lead quality assessments and audits, acting as lead auditor for regulatory and internal inspections.
* Investigate product-related complaints and implement corrective and preventative actions using root cause analysis.
* Support new product introductions and product changes by developing quality plans and change control documentation.
* Monitor quality metrics, identify areas for improvement, and implement process enhancements.
* Train and guide colleagues in quality standards, methods, and compliance requirements.
* Manage multiple projects and priorities, ensuring strategic and operational goals are achieved.
Skills & Attributes
* Strong technical knowledge of quality methods, statistical analysis, process capability, sampling, and testing principles.
* Experience in regulatory compliance for medical devices and/or consumer products.
* Excellent communication skills with the ability to influence senior stakeholders.
* Strong project and resource management experience, with the ability to lead cross-functional initiatives.
* Ability to balance strategic planning with hands-on execution and problem-solving.
Education & Experience
* University degree in Engineering, Quality, Science, or a related discipline.
* 8+ years of technical experience in quality roles, ideally spanning consumer products and medical devices.
* Demonstrable knowledge of MDD/MDR, ISO 13485, MHRA, and medical device risk management.
* Track record of successfully managing quality projects, audits, and compliance activities across multiple functions.
This is an excellent opportunity for a senior quality professional to make a real impact in a global, multi-regional business.