Sr. Director of Quality Assurance (IVD & FDA)

Must have experience working with an In Vitro Diagnostics (IVD) DevicesPosition: Director of Quality Assurance with FDA and In Vitro Diagnostics (IVD) devices. (IVD)Full-Time Direct Hire SalaryClient Location: Toronto, Ontario Canada areaOur direct client is looking for a Director of Quality Assurance (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. client will pay travel expenses.***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 timeor wiling to be in the office 3 days a weekor 24 weeks a month for the next 15 months and they can revaluate once they are submitted to the FDAA 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.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) IndustryMust have hands-on experience working with an In Vitro Diagnostics (IVD) company in Quality AssuranceAt least 2 years of Hands-on working experience with In Vitro diagnostic (IVD) devices.Min 5 years of Management with at least 5 direct reportsMin 2 years of Director Level experience (including some hands on)Strong experience with QMS Systems including implementation or the build out of a QMS SystemMust have experience with any type of New ProductDevice from ideation to full product launchHas led an organization through an ISO 13485 auditExtensive cGMP and regulatory experienceStrong knowledge of quality management practices, cGMPs, and current trends in quality and regulatory compliance, especially across reagentschemistry, consumables, and instrumentationWorking in a startup, understanding Change Control Lite - Nice to haveExceptional organizational and leadership abilities, with a proven track record in quality assurance management. Strong communication skills for effective debate, persuasion, and collaborationExperience managing reams, hands on managers, grow, mentor, coach and guideNice to have Gone though all phases:Phase 1 - R&DPhase 2 - PrototypePhase 3 - Clinical TrialsPhase 4 - V & V - Verification and ValidationPhase 5 - Commercial LaunchQuality 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 pliance & 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.*** 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.

Created: 2025-02-23