Quality Assurance Associate

2 months ago

Kitchener, Canada FluidAI Medical Full time

**Position: Quality Assurance Associate**

**Summary**

As a Quality Assurance Associate, you will support the continuous development, implementation, and improvement of FluidAI’s Quality Management System as well as provide support for FluidAI’s Quality Engineer in documentation and V&V activities for product development and release. This includes working with both the Quality Assurance team as well as the development and manufacturing teams.

This position will require you to come into our offices located in Kitchener, ON, as required.

**Who We Are**

FluidAI Medical aims to create a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. FluidAI’s platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can enhance the delivery of care. FluidAI’s technology is being built with the goal of decreasing surgeon’s response time to potential complications, making patient recovery easier, and hopefully saving lives.

**Responsibilities**
- Assist teams with proper implementation of procedures.
- Responsible for verification and maintenance activities of equipment used in manufacturing and product development.
- Conduct investigation of non-conformities and support in managing Non-Conformance Reports.
- Review, analyze, and report on quality discrepancies related to product and relevant manufacturing processes.
- Support product development in design verification and validation activities including drafting and improvement of test protocols.
- Observe trends in implemented quality procedures and collect relevant data to help measure effectiveness of quality systems and drive improvements.
- Help develop, implement, and investigate corrective and preventive actions for recurring discrepancies and/or opportunities for improvement.
- Support in preparing documentation required for Engineering Change Orders for product changes and release.
- Assist in maintaining a constant state of readiness for industry audits.
- Support the continuous improvement and maintenance of product Risk Management File and ensuring appropriate linkage, regulatory compliance, and alignment with product changes and acquisition of new information is captured.
- Develop processes and draft standard procedures and work instructions in collaboration with relevant teams.

**Skills and Qualifications**
- Organized with high attention to detail.
- Quality-conscious mindset.
- Ability to comprehend, interpret and connect large amounts of information.
- Ability to work independently.
- High level of integrity and accountability.
- Strong problem identification and problem resolution skills.
- Familiarity with medical device manufacturing processes.
- Passion for delivering high quality products.
- Excellent written and verbal communication skills.
- Understanding of latest industry standards, reading, and navigating legal-style documents.
- Experience in extensive writing, reviewing, and editing of written material.
- Flexibility and ability to adapt to changing priorities.
- Excellent team player.

**Preferred/Bonus Qualifications**
- Experience in GMP, GDP, and/or GLP practices preferred.
- Knowledge of continuous improvement tools and statistical process assessment.
- Understanding of Medical Device design controls and risk management requirements.
- Familiarity with Health Canada’s and/or FDA’s medical device regulations.
- Experience in test protocol development.

**Job Type**: Contract

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