Job Title: Head of Quality Assurance & Control
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Location: Campania (Hybrid with a fly-in fly-out setup possible)
Responsibilities
* Oversee and ensure compliance with GMP, ISO 13485, MDD, and MDR requirements for sterile manufacturing of Class III medical devices
* Lead and validate terminal sterilization processes to meet industry and regulatory standards
* Develop, implement, and maintain an Electronic Quality Management System (eQMS) to support site operations and documentation
* Conduct process validations and ensure continuous improvement of manufacturing protocols; collaborate with cross-functional teams to ensure alignment with regulatory and safety standards; provide leadership and guidance within a small team environment (approximately 20 people onsite)
* Maintain accurate records and documentation to support audits and regulatory reviews
* Foster a culture of quality and compliance in all aspects of production and product release
* Stay current with industry trends, regulatory updates, and best practices in sterile medical device manufacturing. xrdztoy
Company
Currently representing a key player in the healthcare/lifesciences private equity, with +3BN in assets under management, that are about to acquire a class III Medical device manufacturer in the South of Italy.