Quality Systems Specialist

2 weeks ago

Kitchener, Canada FluidAI Medical Full time

**Position: Quality Systems Specialist**

**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.
- Unlimited vacation and paid parental leave.

**Job Summary**

As a Quality Systems Specialist, you will support the QA Manager with the maintenance, implementation, and improvement of FluidAI’s Quality Management System. This includes interim management of quality systems in the absence of the QA manager. We are looking for someone self-driven and able to adapt in a rapidly growing organization, who is quality-oriented, and can quickly tackle new challenges as they arise.

You will work with a high performing cross-functional team interfacing with product development, manufacturing, and quality assurance functions at various stages, including product development, product realization, and post-market surveillance. 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 advancing a meaningful product, this is for you

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

**Responsibilities**:

- Work alongside the Quality Manager in maintaining and improving FluidAI’s Quality Management System and ensure continuous compliance to ISO 13485 and applicable industry/regulatory requirements.
- Review, update, and ensure proper implementation company’s Standard Operating Procedures and Work Instructions across teams.
- Support in managing internal audits, MDSAP audits, and regulatory inspections and contribute to maintaining and promoting a constant state of readiness for industry audits and inspections.
- Lead the implementation of the training program including driving improvements.
- Work alongside different functions to solicit feedback and address gaps and improvements specific quality processes and documentation.
- Observe and report trends in implemented quality procedures and collect relevant data to help management 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 general quality assurance functions and documentation, as required (e.g., NCRs, QA Inspections, post-market surveillance activities, management review, measuring/driving quality objectives, etc.).

**Qualifications**
- 3-5 years of working experience within MedTech or biotechnology industry with exposure to all aspects of quality systems and product lifecycle.
- Bachelor’s Degree (BSc, BASc, BA) in Biomedical Sciences, Biology, Health Sciences, Biomedical Engineering, or related discipline.
- Strong leadership and collaboration skills, and an appreciation of how quality enables the organization to meet its objectives.
- Working understanding of the quality systems, culture, and mindset.
- Working understanding of process change management including impact of change.
- Understanding of latest industry standards as well as reading and navigating legal-style documents.
- Direct experience in the conduct of at least one external audit, auditing practices, and appropriate conduct during verbal and/or written communication with auditors, inspectors, and/or auditing bodies.
- Knowledge of continuous improvement tools and statistical process assessment.
- Familiarity with medical device manufacturing processes.
- Experience with post-market surveillance activities and linkage to product lifecycle.
- Organized with high attention to detail.
- High level of integrity and ethical conduct.
- Ability to work independently with mínimal supervision.
- Passion for delivering high quality products.

**Bonus Qualifications**
- Post-graduate degree (e.g., MS) or certificate in Q

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