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Company Description

O-Two Medical Technologies Inc. is a world leader in the design and production of emergency respiratory care devices. Offering a complete range of products like Analgesic Gas Delivery Systems, Resuscitators and Automatic Transport Ventilators, CPR devices, and airway management tools, the company is renowned globally for its quality and performance. With a strong emphasis on research, innovation, and collaboration. The company is dedicated to advancing emergency medicine through pioneering product development and engineering expertise.

Role Description

This is an on-site role located in Brampton, ON, for a Senior Quality Assurance Specialist. The role involves identifying process improvements, maintaining regulatory standards, and collaborating with various teams to ensure product quality and reliability.

Overview

As a senior member of the Quality Assurance and Regulatory Affairs (QA/RA) team at O-Two Medical Technologies, the Senior Quality Assurance Specialist plays a critical role in ensuring compliance and continuous improvement of our quality systems. This position requires, post-market vigilance, audit readiness, and cross-functional collaboration to maintain ISO 13485 and MDSAP compliance, as well as regulatory requirements from Health Canada, FDA, EU MDR, and other global markets.

Key Responsibilities

Quality Assurance

- Lead internal and external audits (ISO 13485, MDSAP, FDA) and act as subject matter expert for regulatory and quality-related questions.
- Oversee CAPA, non-conformance investigations, and effectiveness verification processes.
- Review and approve controlled documents (SOPs, work instructions, validation protocols, etc.) from a regulatory and quality perspective.
- Support continuous improvement of the Quality Management System (QMS) to meet evolving regulatory requirements.
- Review labeling, Instructions for Use (IFUs), and marketing materials for regulatory compliance.

Post-Market Surveillance & Risk Management





- Support post-market surveillance activities, including vigilance reporting (e.g., MDR, FDA MDR) and complaint investigations.
- Support RA to perform periodic trend analysis and coordinate field actions or recalls as necessary.
- Support the preparation and submission of global regulatory applications, including Health Canada device licenses, FDA 510(k), CE Mark technical documentation, and international registrations.
- Assist regulatory strategies for new product introductions, product modifications, and global market access.
- Assist the regulatory team in providing regulatory input to cross-functional teams during product development, change control, and risk management activities.
- Assist the regulatory team to maintain and oversee regulatory documentation, including Technical Files, Design History Files (DHF), and Device Master Records (DMR).

Qualifications & Experience

- Bachelor’s degree in science, engineering, life sciences, or a related field (required).
- Advanced training and certification in Quality Assurance (e.g., ASQ).
- Minimum 5 years of experience in Quality Assurance in the medical device industry.
- Hands-on experience with ISO 13485, MDSAP, EU MDR, FDA QSR (21 CFR Part 820), and Health Canada regulations.
- Experience leading audits and direct interactions with regulatory bodies.
- Strong knowledge of design controls, risk management (ISO 14971), and post-market surveillance requirements.

Key Skills & Attributes

- Strategic thinker with the ability to interpret and apply global regulatory requirements effectively.
- Strong leadership and project management skills with a focus on cross-functional collaboration.
- High attention to detail and accuracy in preparing technical documentation.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced and deadline-driven environment.
- Self-motivated with a proactive mindset and robust problem-solving abilities.
- Proficiency with QMS software, Microsoft Office Suite, and document control tools.

Apply on Kit Job: kitjob.ca/job/2fsrnf

📌 Senior Quality Assurance Specialist (Brampton)
🏢 O-Two Medical Technologies
📍 Brampton