Quality Assurance/non-conformance Associate

3 weeks ago

Kitchener, Canada FluidAI Medical Full time

**Company Description**:
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.

**Job Summary**:
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.

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

**Responsibilities**:

- 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.

**Qualifications**:

- 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.

**Bonus Qualifications**:

- 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.

**Job Type**: Contract

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