Our client, a leading international med tech company, are looking for the pivotal role of Head of Site Quality. Collaborating closely with executive leadership and a dedicated quality team, you will be responsible for the enhancement of the Quality Management System (QMS) to ensure continuous improvement and regulatory compliance.
Responsibilities:
* Spearhead Quality Leadership & Compliance, overseeing QA/QC functions and ensuring adherence to regulatory standards
* Champion Quality Management System (QMS) optimisation and efficiency
* Collaborate with site and global leadership to navigate process changes, advocate for site-specific requirements, and implement customer-centric solutions during change management
* Foster Team Development & Performance by cultivating a high-performing quality department
* Lead Audits and Reporting activities, conducting Quality Management Reviews, monitoring KPIs, hosting audits, and serving as the site's representative
* Navigate FDA/EPA-regulated manufacturing environments with precision
* Utilise Regulatory and Quality Expertise encompassing ISO, FDA, cGMPs, CFR, Controls, CAPA, and more
* Manage Complaints, audits, and risk effectively using quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools
Qualifications:
* Hold a degree in Science, Business, Engineering, or related fields (practical expertise also considered)
* Quality Assurance, Quality Engineering, or Manufacturing Operations
* Experience in Life Sciences sectors such as Biotechnology, Medical Device, Biopharma, or similar industries
On offer is the opportunity to work for a marquee name in the med tech industry and contribute towards manufacturing operations.
Desired Skills and Experience
Quality Assurance, Management, ISO 13485, FDA, CAPA, QMS, CFR, Operations, Manufacturing, Continuous Improvement, Medical Device