Technical Quality Assurance Associate

2 weeks ago

Pickering, Canada BTNX Inc. Full time

**Company Overview**

BTNX Inc. (BTNX) is a biotechnology company and a world leader in rapid, point-of-care diagnostics. We specialize in innovation, research, development, and manufacturing of advanced in-vitro diagnostic (IVD) tests for laboratories, clinics, hospitals, and physician offices. Headquartered in Pickering, ON, BTNX’s core business operations are within Canada & USA, with international sales spanning dozens of countries around the globe.

**Role Overview**

The TECHNICAL ASSOCIATE is responsible for the up keeping and monitoring of the quality of IVDs, to ensure its effective use and functionality. This position requires an in-depth knowledge of different facets of toxicology, chemistry, and biomedicine of to employ in the development of IVDs. The TECHNICAL ASSOCIATE is responsible for all the tasks outlined below to ensure BTNX products are meeting the highest of quality standards.

**Job Requirements**:

- Assist with Technical Issues including medical device complaint handling
- Perform quality control testing on finished products
- Review certificates of Analysis and other technical documents for products
- Perform QC verification on the product as necessary
- Report any out of specification to QA manager and participate in investigation as required
- Perform new product testing, such as sensitivity testing, stability testing, etc.
- Perform proficiency testing and value assignment for products
- Assist in creation and review technical documents, such as product inserts, sale sheets, and presentations.
- Assist in creation of quality assurance documents such as design control, shipment control, batch release certificates, and customer supporting documents
- Assists in preparation of registration documents for Health Canada, FDA, and CE conformity
- Assist in maintaining the ISO 13485 conformity and quality management SOPs

**Qualifications**:

- Bachelor's or Master’s Degree in Toxicology, pharmacology, chemistry or other relevant discipline
- 0-3 years’ experience as a Toxicologist, Scientist, or suitable combination of aforementioned disciplines
- Strong scientific background associated with the development of lateral flow immunoassay devices preferred
- Knowledge of ISO13485:2016, and regulatory requirements (Health Canada, US FDA, and IVD Regulations) preferred.
- Basic wet chemistry skills such as weighing, measurements, solution preparation, and dilutions.
- Strong critical thinking and problem solving skills
- High attention to details and organization skills
- Strong communication skills (both oral and written)
- Ability to multitask in a fast past environment.
- Proficient in MS Office

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