Head of Quality
Head of Quality position at a Manufacturing Plant
Reporting directly to Global Head of Quality
About Our Client
Global manufacturer of diagnostic tests, focusing on infectious disease, cardiometabolic, and toxicology testing.
* Establishing, implementing and maintaining Quality Management System by providing leadership of Quality function. (Design, Implementation, Auditing and Continual Improvement):
* Effective communication and engagement with all other departments (including both factory and commercial) to facilitate their engagement and execution of quality-focused, compliant activities.
* Development and maintenance of organizations' policy and expertise for quality management systems
* Handling and managing QMS external audits, Notified Body Audits, supplier audits
* Quality Assurance of new product development process activities meeting required industry and regulatory standard for devices.
* Managing WHO, US Government, cGMP, GxD, ISO etc. guidelines and quality systems. This includes both theoretical knowledge and practical "sleeves rolled up" application of requirements including for example Product complaints, validations, CAPAs, labeling controls, product release activities
The Successful Applicant
Mandatory Qualification / Skills:
* Minimum 15 years of work experience, including at least 10 years in Quality Assurance and Quality Control in manufacturing.
* At least 5 years work experience in multinational company
* Experience in Medical Devices and/or IVD (In-vitro Diagnostics).
* (If no medical device history but a very strong Life Science Healthcare Industry experience, this is possible).
* Strong written and spoken English skills.
* Demonstrates leadership skills and behaviors
* Demonstrates management skills and behaviors
* Science and/or engineering or other relevant tertiary qualification
* Experience in IVD (In-vitro Diagnostics).
* Possess thorough understanding of, and working experience with ISO 13485, ISO 14971 and ISO 9001 quality system requirements.
* Reasonable knowledge of US 21CFR820 and 21CFR803
What's on Offer
15-18M yen / year