Job Description

About the Role

The

Quality Assurance Manager

will lead and maintain Sonic Incytes' Quality Management System (QMS), ensuring compliance with FDA, ISO 13485, MDSAP and Health Canada requirements. This role will manage all quality processes across design, manufacturing, and post-market activities and oversee both internal and external audits. The QA Manager will also play a key role in sustaining our cloud-based QMS (eQMS) platform, supporting continuous improvement across all teams.

This role reports to the CEO / Director of Manufacturing and Supply Chain.

Key Responsibilities:

Manage and maintain the cloud-based Quality Management System (QMS), including documentation control, CAPA, NCRs, SCARs, and change control (ECR/ECN).

Ensure compliance with FDA, ISO 13485, MDSAP, and Health Canada requirements.

Lead internal audits and coordinate external audits (e.g., notified bodies, FDA inspections, supplier audits).

Oversee and continuously improve cloud-based QMS (e.g., eQMS system administration, workflows, templates, and user access).

Support Design Control and Risk Management activities throughout the product lifecycle.

Manage supplier quality processes including qualification, monitoring, and corrective actions.

Maintain compliance records and ensure documentation is current, traceable, and audit-ready.

Provide training to staff on quality system procedures and regulatory requirements.

Partner with cross-functional teams (R&D, Manufacturing, Regulatory, Operations) to implement quality improvements and preventive actions.

Support management review meetings and quality metrics reporting.

Qualifications:

Bachelor's degree in Engineering, Sciences, or a related technical discipline.

2-5 years of experience in quality assurance within a medical device or regulated industry environment. Medical device experience is preferred.

Strong understanding of ISO 13485, MDSAP, FDA 21 CFR Parts 820, 803, 806, and 807 (Subparts A-D), as well as Health Canada Medical Devices Regulations, Part 1 (SOR/98-282), and related global regulatory frameworks.

Experience managing or administrating cloud-based QMS tools. We use Cloudtheapp.

Demonstrated success in supporting internal/external audits and regulatory inspections.

Knowledge of risk management (ISO 14971) and design control principles.

Excellent organizational, documentation, and communication skills.

Self-motivated, detail-oriented, and capable of working in a fast-paced, cross-functional environment.

About Sonic Incytes

Sonic Incytes is committed to enhancing patient care through innovative diagnostic solutions. The company's flagship product, VELACUR(TM), equips physicians with an advanced liver imaging tool to combat the growing epidemic of fatty liver disease. VELACUR is an AI guided 3D S-WAVE ultrasound elastography device that measures liver stiffness and attenuation, the two key indicators of fatty liver disease.

Compensation:

Competitive Salary:

Between $70,000 and $95,000 per annum, commensurate with experience.

Comprehensive Health Benefits:

We provide medical, dental, vision, life, and disability insurance starting from day one.

Paid Vacation:

Receive 3 weeks of paid vacation annually.

Employee Stock-Option Plan:

Participate in our rewarding employee stock-option award plan.

Why Should you Join Sonic Incytes?

Rare opportunity to join a company actively making a difference for patients who are afflicted with chronic liver disease, an emerging global health crisis. Join an energetic and diverse team who are endlessly curious and wildly passionate about what we do. A chance to work within a fast-paced, growing start-up company with lots of opportunities for personal and professional development.




We are proud to be an equal opportunity employer, committed to creating a diverse and inclusive workplace for all. We believe that diverse perspectives drive innovation and success. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.



Are you wanting to have a positive impact and up for a new challenge? If yes, we want to hear from you!



Due to the high volume of applicants, only those selected for an interview will be contacted.

For more information about the company, please visit

www.sonicincytes.com

.