Our direct client is looking for a Director of Quality Assurance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.
The Client is open to candidates located in Canada or based in the United States. client will pay travel expenses.
Travel Requirement:
50% Remote from Home and 2 weeks month onsite in Toronto Canada area
Overview
Direct of QA will need to have strong QA background, set up the Strategy and adjust the Strategy if needed.
Must have experience working with In Vitro Diagnostics (IVD) Devices development in a manufacturing environment with FDA regulation / FDA regulatory.
A well funded, early stage in vitro diagnostics (IVD) company is seeking an energetic leader to manage and lead its quality assurance efforts. Specifically, the company is exiting Phase 2 of its product develop process and readying for clinical trials in 2025 for its multi-analyte POC instrument system and reagents. The QA team is currently small but is expected to evolve and grow within the coming year, led by this individual. Our client is seeking an organized and energetic individual to lead the company in implementing our Quality Management System (QMS) and embracing a quality mindset. As the Head of Quality Assurance, you will lead the company's QMS, ensuring rigorous compliance with global standards and driving a strategic approach to quality. You will implement, monitor, and continuously improve quality assurance processes, aligning with Health Canada, FDA, and EU regulations and corporate policies. This position will provide oversight across the full product lifecycle, from development to commercial operations, supporting teams in assay, consumable, instrumentation, manufacturing, and operations.
Key Responsibilities:
Education :
Experience:
Travel Requirement:
Nice to have Gone though all phases:
Benefits: • Paid time off • Monday to Friday schedule • Full-time, permanent position
Professional Reference Check will be required!
Overview Recap:
Direct of QA will need to have strong QA background, set up the Strategy and adjust the Strategy if needed.
Must have experience working with In Vitro Diagnostics (IVD) Devices development in a manufacturing environment with FDA regulation / FDA regulatory.
If you are interested, please send me your updated Word Resume, along with your direct phone number and email.
Please note, I am based in the USA, Eastern Time Zone.
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