Quality System Architect at Techno-Diffusion Company Limited

Quality System Architect for first-in-Nigeria life-saving device

Project VentShot is on track to deliver the first export-quality medical ventilators manufactured on the African continent. For many patients with severe respiratory ailments there is no alternative to ventilators, but the cost and complexity of traditional systems has left Africa with less than 1% of the ventilator capacity it needs.

We have already licensed a proven ventilator design with US FDA approval and brought together a world-class team of engineers, business people, and medical professionals to build it in Lagos, Nigeria. Now we are looking for an experienced and driven Quality Systems Architect to design and implement the quality management system.

Your efforts and the resulting QMS will help us to reliably deliver and provide ongoing support and maintenance for thousands of affordable, life-saving ventilators across the continent.

The Role:

• Quickly absorb and synthesize all relevant national and international standards including ISO 13485, ISO 9000, NAFDAC etc.
• Design, develop, test, and implement a unique and tailor-made quality management system, adapting all relevant international standards to the local environment
• Thoroughly document, present, and defend your QMS internally to leadership and externally with regulators
• Lead all regulatory submissions and navigate the nascent regulatory environment for medical device manufacturing in Nigeria
• Design, recruit, and manage our Quality Team and all personnel responsible for implementing and maintaining the QMS
• Embrace additional responsibilities as they arise relating to Quality, Compliance, Data, and any other specific skills you add to the Leadership Team.

This role reports to the Managing Director

You Are:

• Technical: able to quickly absorb, compare, contrast, and synthesize various data, processes, and frameworks
• Logical: data-driven and able to present clearly justified proposals and decisions
• Rigorous: structured and thoughtful in analysis, and clear and factual in communications
• Curious: open minded, experimental, creative conceptual problem-solver, eager to consider new ideas and learn
• Driven: impatient, urgent, and quick to demand results from self and others
• Resilient: comfortable with change, pressure, and the drive to move forward faster even in the face of obstacles
• Autonomous: able to evaluate risk and act strategically and decisively
• Structured: engaged intensively in detail, process, structure, and follow-through
• Organized: able to simultaneously manage multiple complex projects in great detail
• Reliable: able to conduct work independently and achieve results with limited direct oversight

Required skills and experience:

• Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience
• 7+ years industrial experience, three years or more in a NAFDAC regulated industry with medical devices or similar industry required.
• Must have experience in project management of change programs
• Firsthand experience of audits by regulatory authorities.
• Extensive experience of developing and delivering effective training on Quality Systems and Processes
• Demonstrated track record and success in team building skills
• Demonstrated experience of people management

Other preferred skills and experience include:

• Experience in hosting and leading audits from NAFDAC and other regulatory authorities
• Experience navigating a first-in-country regulatory process
• Experience managing quality in medical device or pharmaceutical manufacturing
• Experience leading the design and implementation of a brand new QMS
• Experience working directly with doctors for testing and data collection in a medical environment
• Direct experience with implementing ISO 13485 standard
• Experience with clean room certification and operations
• Experience buying, importing, certifying, installing, and/or maintaining medical ventilators
• Demonstrated passion for improving the quality of life in Nigeria and beyond

About Project VentShot:

Project VentShot is a research, development, adaption and commercialization effort which is part of Techno-Diffusion Company Limited. Techno-Diffusion (www.techno-diffusion.co) is a company that seeks to uncover life changing innovations and technologies to bring them to needed markets. We take discovered technologies and work with target audiences to localize them via novel pilot & training programs. And we aim to move nations, organizations and communities forward by diligent rapid execution of adapted technologies at scale