Quality Assurance & Non-Conformance Associate (Co-Op)
Kitchener, ON, Canada
Posted on Friday, September 22, 2023
FluidAI is creating 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. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can support earlier detection of deadly complications and enhance the delivery of care.
We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.
Why join FluidAI?
- Mission to save lives and improve patient care with technology that’s already deployed on patients in real-world settings.
- Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
- Gain exposure across the entire technical stack, from novel sensing technologies and proprietary hardware to mobile/web software and ML algorithms.
- Personal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.
- Regular offsite activities – past events include rafting, axe-throwing, sports leagues, and the usual BBQ.
This role centers around investigating product and manufacturing-related non-conformities to assist in the implementation of quality requirements, manufacturing procedures, and improve product development. We’re looking for a motivated student keen to learn about sensor processing, human factors, and process design with a quality-centric mindset.
This position will be heavily involved with both the Quality team as well as the Manufacturing team. In this position, you will investigate non-conformance incidents within manufacturing and quality procedures. This position will be responsible for conducting root cause analyses and utilize statistics/data analysis, human factors, and problem-solving skills to drive product and process changes.
Day-to-day activities will include working with production technicians to identify non-conformities, planning and prioritizing investigations, completing investigations and root cause analysis, and carrying out dispositions, where required. Additional activities include working with manufacturing and product development teams to drive process changes. This position will expose the candidate to aspects of manufacturing and quality within an ISO 13485 compliant environment. This exposure will set-up students to succeed in the MedTech manufacturing industry. Working in a start-up will give students an opportunity to explore many aspects of medical devices.
It's not everyday that you get a chance to make a direct impact on people's health. If you're looking to join a strong team for a meaningful product, this is for you!
- Conduct non-conformance (NCR) investigations using root cause analysis techniques.
- Analyze production data to determine source(s) of non-conformities.
- Assist in the development of new manufacturing and quality procedures.
- Document investigations and procedures as per ISO 13485:2016 requirements
- Work with a multidisciplinary team to promote design changes to improve production line efficiency.
These are some of the skills we are looking for in an ideal candidate. If you check some but not all of these boxes, please apply anyway!
- Minimum 1-2 years of coursework in Biomedical, Nanotechnology, Chemical, Mechanical, Mechatronics, Biological, Chemical, or Systems Engineering or other Engineering Discipline
- 4+ months work experience in medical devices, quality assurance, and/or manufacturing
- Familiarity with root cause analysis methods
- Strong documentation skills in workplace environment
- Proficient in MS Office including Excel.
- Problem solving skills.
- Solid understanding of foundational statistics and experimental design including sampling methods, descriptive statistics, and statistical testing methods.
- Experience in ISO 13485 or ISO 9001 compliant workplace
- Familiarity with GMP/GLP, and GDP is an asset.
- Familiarity with Atlassian Suite (Jira, Confluence, etc.) is an asset.
- Familiarity with an eQMS is an asset.