Director of Quality Assurance & Compliance (IVD & FDA)

Job Description

Position: Director of Quality Assurance & Compliance

Full-Time Direct Hire Salary

Client Location: Toronto, Ontario Canada area Our direct client is looking for a Director of Quality Assurance & Compliance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.

Client is located in the Toronto, Ontario Canada area. They are open to candidates located in Canada or based in the United States. If not local to Canada, you must be able to travel and work onsite in Toronto, Canada 50% of the time for the next 12 months plus. Preferably every other week - client will pay travel expenses.

On-site 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 15 months and they can revaluate once they are submitted to the FDA

A well funded, early stage in vitrodiagnostics (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.

Skills Required:

Education: Bachelor’s degree in Science, Engineering, or a related field. Advanced degree preferred.

Experience:

• 10 + years of overall experience in Quality Assurance within: pharmaceutical, biotechnology, medical devices, or In Vitro Diagnostics (IVD) Industry
• 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 years of Director Level experience (including some hands on)
• 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

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

What you'll do:

• Quality Management System Leadership:

Oversee and manage the organization’s QMS, ensuring full compliance with all relevant regulatory standards and guidelines, including Health Canada, FDA, and EU regulations.

• Strategic Quality Assurance:

Develop and execute a strategic approach to quality assurance, aligning with corporate objectives to enhance product quality and operational excellence.

• Process Harmonization:

Design, implement, and continuously improve standardized quality processes across the organization, securing buy-in to drive adoption and adherence.

• Compliance & Standards Alignment:

Keep quality system instructions and procedures current, ensuring alignment with the latest medical device standards and regulatory expectations across global and internal guidelines.

• Cross-functional Collaboration:

Work closely with assay, consumable, instrumentation, manufacturing, and operations teams, guiding them in quality assurance practices and implementing the QMS effectively across all areas.

• Issue Resolution:

Identify and communicate compliance and quality issues, proposing and implementing effective solutions with senior leadership.

• Mentorship & Leadership:

Foster growth and development within the quality team, providing mentorship and leadership to drive excellence in quality practices.

• Skill Development:

Assess, manage, and enhance skill sets and competencies within the quality team and across the organization.

What you'll get:

• Impactful Work:

An opportunity to change the face of medical diagnostics and drive transformative advancements in healthcare.

• Collaborative Environment:

Work alongside a high-performing, motivated team passionate about quality and innovation.

• Competitive Compensation:

A competitive salary and benefits package designed to attract and retain top talent.

• Growth-Oriented Culture:

An environment where your talent, ideas, and expertise are valued every day, empowering you to make meaningful contributions and thrive professionally.

*** If not local, then TRAVEL to Toronto, Ontario Canada area is required. At least 50% Plus of the time.

*** 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.

Job Type: Full-time

Pay: From $160,000.00 per year

Benefits:

• Paid time off

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Toronto, ON: reliably commute or plan to relocate before starting work (preferred)

Education:

• Bachelor's Degree (required)

Experience:

• Quality assurance: 10 years (required)
• cGMPs: 4 years (required)
• CAPA's: 2 years (required)
• Health Canada, FDA, and EU regulations: 4 years (required)
• QA Management: 5 years (required)
• In Vitro Diagnostics (IVD): 2 years (required)
• QMS System: 5 years (required)
• ISO 13485: 4 years (required)

Work Location: Hybrid remote in Toronto, ON

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