Associate Director, Quality Assurance – TalentSphere

Title of the Job: Associate Director, Quality Assurance

Location: Vancouver, BC

Job Description: Associate Director, Quality Assurance
Location: Vancouver, BC
Position: Permanent, Full-Time
Workplace Type: On site
Salary Range: $140,000 – $160,000 plus bonusFurthering your QA management career and contributing to the growth of an exceptional diagnostics company?Our client is a commercial-stage diagnostics company focused on autoimmune disorders to personalize and optimize treatment for patients globally. They are building a values-driven organization committed to transforming illness into wellness.SUMMARYThey 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 the authority to work in Canada.Benefits package available.TSSHP LI-TS1
#16526390

Company Name: TalentSphere

Salary: $140000 – 160000 per year

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