Quality Systems Specialist - Kitchener, Canada - FluidAI Medical
Description
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 realworld settings.
- Work with a highperforming and crossfunctional 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 careerfocused development and training with access to workshops, coursework, and experienced mentors/consultants.
- Regular offsite activities past events include rafting, axethrowing, 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.
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.
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, postmarket surveillance activities, management review, measuring/driving quality objectives, etc.).
Qualifications
- 35 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 legalstyle 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 postmarket 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
- Postgraduate degree (e.g., MS) or certificate in Q
More jobs from FluidAI Medical
-
Software Quality Assurance Engineer
Kitchener, Canada - 4 days ago
-
Software Quality Test Engineer REMOTE
Kitchener, ON, Canada - 4 days ago
-
Data Lead
Kitchener, Canada - 2 weeks ago
-
Business Development Sepcialist
Kitchener, Canada - 1 day ago
-
Production Technician
Kitchener, Canada - 1 week ago
-
Regulatory Affairs Specialist
Kitchener, Canada - 1 week ago