Associate Director, Quality Assurance
Job Posting ID: #16526390
Location: Vancouver, BC, Canada
Position: Permanent, Full-Time
Workplace Type: On site
Salary Range: $140,000 – $160,000 plus bonus
ABOUT AUGUREX
Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex’s lead diagnostic test, JOINTstat®, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis, lupus and other autoimmune conditions. SPINEstat® expands Augurex’s biomarker-informed diagnostic portfolio into axial spondyloarthritis (axSpA) and has the potential to bring a novel first-in-class diagnostic to this area of significant unmet medical need.
WHY WORK WITH US
At Augurex, we’re a close-knit, passionate team that genuinely cares about making a difference in people’s lives. From the laboratory bench through to clinical development and commercialization, we are building an organization based on our values and a commitment to transform illness into wellness.
SUMMARY
We are seeking a highly experienced Head of Quality Assurance to lead the Quality Assurance team, ensuring compliance with quality standards for our Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD). This role collaborates with cross-functional teams to drive continuous improvement and supports product expansion initiatives.
ROLE AND RESPONSIBILITIES
- Lead the Quality Assurance team to maintain QMS compliance with MDSAP, ISO, GxP, and other standards.
- Manage external audits and corrective actions for MDSAP, ISO, FDA, and other regulatory bodies.
- Support new product development, design controls, and risk management processes.
- Oversee internal audits, non-conformances, CAPA, and customer complaints.
- Identify and implement quality improvements to enhance product and customer satisfaction.
- Act as interim PRRC to ensure compliance with conformity, post-market, and reporting requirements.
- Provide technical training and promote a culture of quality and compliance.
QUALIFICATIONS AND EXPERIENCE
- Master’s degree or equivalent with 8+ years in quality assurance/control, including management roles in diagnostics or medical devices.
- Expertise in MDSAP, ISO 13485, ISO 14971, CFR 820, and related regulations.
- Proven experience in managing audits and eQMS platforms.
- Strong leadership, problem-solving, and superior communication skills.
- Ability to work independently in a dynamic, fast-paced environment.
The candidate must have legal authority to work in Canada.
BENEFITS
- Proximity to SkyTrain and bike routes
- Free parking near by
- Teambuilding Company Events
- Extended Healthcare Benefits
- Flexible schedule
- On-site gym
- Professional Development Support
For questions regarding this opportunity and application process, please contact Carla Campbell, Executive Talent Consultant, Life Sciences at ccampbell@talentsphere.ca or at 1-778-807-9777 ext738.