Quality Control Associate

FluidAI Medical; Kitchener; On-site; CAD 50,000 - 70,000; Full time

Job summary

FluidAI Medical seeks a motivated student to join their Quality team in a role focused on investigating product and manufacturing-related non-conformities. This opportunity offers valuable exposure to sensor processing and human factors, contributing to impactful improvements in healthcare technology within an ISO compliant environment.

Benefits

Career-focused development and training

Access to workshops and mentorship

Regular offsite team-building activities

Qualifications

• Coursework in Biomedical, Chemical, Mechanical, or related engineering disciplines.
• 4+ months work experience in medical devices or quality assurance.
• Solid understanding of foundational statistics and experimental design.

Responsibilities

• Assist with conducting production line testing to mitigate product failures.
• Analyze production data to determine sources of non-conformities.
• Document investigations and procedures as per ISO 13485:2016 requirements.

Skills

Attention to detail

Documentation skills

Data analysis

Problem-solving

Root cause analysis

Knowledge of statistics

Education

Minimum 1-2 years of coursework in Biomedical or related Engineering disciplines

Tools

MS Office

VBA

Python

Atlassian Suite (Jira, Confluence)

Job 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.

This role is made available thanks to funding secured through SWPP Grants. As such, we are seeking candidates who are eligible.

As part of the application process, we strongly encourage the inclusion of examples of technical writing such as

• Work Term Reports
• Design Reports
• Proposals
• Technical Research Reports
• 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.

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!

Job Responsibilities:

• Assist with conducting and developing production line testing to mitigate product failures
• Analyze production data to determine source(s) of non-conformities.
• Assist in process improvements and 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 process and design changes to improve production line efficiency.
• Assist in other quality assurance projects as they arise (CAPA investigations, audit preparation, record/document management, assigning quality training, etc.)

Qualifications:

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.
• High attention to detail and standards in work
• 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.
• Familiarity with VBA or Python is an asset