Quality System Architect Vacancy at Techno-Diffusion Company Limited

About the role

Quality System Architect for first-in-Nigeria life-saving device job opportunity is available at Techno-Diffusion Company Limited for individuals who possess Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience.

Job Description

• 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 have 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.

Responsibilities

• 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  Director

Experience and qualifications

• 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

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

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 cleanroom 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

Application deadline

31st December, 2020.

Application details

Interested and qualified candidates should:

apply online

WHO IS Techno-Diffusion Company Limited?

Techno-Diffusion Company Limited catalyzes the sustainable growth and development of people, organizations, regions and nations by creating knowledge-based jobs.

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.