Our direct client is looking for a Director of Quality Assurance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.

• Position: Director of Quality Assurance
• Full-Time Direct Hire Salary
• Client Location: Toronto, Ontario Canada area

Open to onsite options:

• Be in the office full time
• or wiling to be in the office 3 days a week
• or 2/4 weeks a month for the next 18 months and they can revaluate once they are submitted to the FDA

The Client is open to candidates located in Canada or based in the United States. client will pay travel expenses.

TRAVEL to Toronto, Ontario Canada area is required.

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.

• IVD experience should be with: instrument and software and engineering
• IVD experience Nice to have: chemistry, hardware, software, consumable
• Understand CFR820 quality regulations and advancing through FDA
• Understand ISO and QSR and how they evolving with FDA

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:

• Lead the development and implementation of the Quality Management System (QMS) from development to commercial operations.
• Ensure compliance with Health Canada, FDA, EU regulations, and corporate policies across assays, consumables, instrumentation, and manufacturing.
• Manage and mentor a growing QA team, driving a quality-first mindset across the organization.
• Oversee new product development, including R&D, prototyping, clinical trials, validation, and commercialization.
• Lead and prepare the organization for ISO 13485 audits, managing CAPAs and non-conformances.
• Collaborate cross-functionally with product development, manufacturing, and operations teams.

Education:

• Bachelor's degree in Science, Engineering, or a related field. Advanced degree preferred.

Experience:

• Must have hands on experience working with an In Vitro Diagnostics (IVD) company in Quality Assurance
• At least 2 years of Hands on working experience with In Vitro diagnostic (IVD) devices.
• Min 5 years of Management with at least 5 direct reports
• Min 2 - 4 years of Director Level experience (including hands on)
• 10 + years of overall experience in Quality Assurance within Life Science Industry (pharmaceutical, biotechnology, medical devices, or In Vitro Diagnostics (IVD) Industry)
• Strong experience with QMS Systems including implementation or the build out of a QMS System
• Must have experience with any type of New Product/Device from ideation to full product launch
• Has led an organization through an ISO 13485 audit
• Extensive cGMP and regulatory experience
• Strong knowledge of quality management practices, cGMPs, and current trends in quality and regulatory compliance, especially across reagents/chemistry, consumables, and instrumentation
• Working in a startup, understanding Change Control Lite - Nice to have
• Exceptional organizational and leadership abilities, with a proven track record in quality assurance management. Strong communication skills for effective debate, persuasion, and collaboration
• Experience managing reams, hands on managers, grow, mentor, coach and guide
• Understand CFR820 quality regulations and advancing through FDA
• Understand ISO and QSR and how they evolving with FDA

Travel Requirement:

• Must be able to travel to Toronto, Canada, 50% of the time (client covers travel expenses).

Nice to have Gone though all phases:

• Phase 1 - R&D
• Phase 2 - Prototype
• Phase 3 - Clinical Trials
• Phase 4 - V & V - Verification and Validation
• Phase 5 - Commercial Launch

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.

• IVD experience should be with: instrument and software and engineering
• IVD experience Nice to have: chemistry, hardware, software, consumable
• Understand CFR820 quality regulations and advancing through FDA
• Understand ISO and QSR and how they evolving with FDA

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.