Hybrid Quality Engineer — Medical Devices & Compliance

NERv Technology Inc. D.B.A. FluidAI Medical; Kitchener; Hybrid; CAD 70,000 - 85,000; Full time

Job summary

FluidAI Medical in Kitchener, ON is seeking a Quality Assurance professional to lead the design controls, implement ISO 13485/14971 compliant processes, and collaborate with Engineering, Regulatory, and Operations. The role focuses on risk-based quality, documentation, and regulatory submissions across Canada, the US, and international markets.

You will ensure products meet safety and quality standards, drive CAPA and change control, and support post-market activities while working 50% of the

Qualifications

• Bachelor’s degree in engineering or a science-related field.
• 2–5 years of experience working in a medical device or similarly regulated environment.
• Working knowledge of ISO13485:2016, ISO 14971, IEC 60601-1:2005, and other relevant standards.
• Strong knowledge of Quality Concepts, with the judgement to know where requirements can flex and where they can't.
• Comfort making risk-based decisions with incomplete information, and the ability to clearly document and defend your rationale.

Responsibilities

• Use a risk-based approach to quality. Apply rigor where it matters most, and keep things lean where it doesn't.
• Partner with engineering and operations to ensure quality is built into product and processes
• Own the linkage of Design Controls in all stages of the production lifecycle.
• Ensure product, material, and process specifications are clear, unambiguous, and practical for production.
• Create test methods and strategies for existing and new products, backed by sound statistical rationale.
• Plan, execute, and analyze test method/process validations.
• Lead and support component/product inspection and qualification activities.
• Support identification, auditing, and onboarding of new suppliers to ensure compliance and business continuity.
• Create and maintain process risk documentation in line with ISO 14971, and evaluate process risks to set appropriate controls throughout the product lifecycle
• Lead investigation and timely closure of non-conformances and CAPAs.
• Assess engineering change for quality and regulatory impact, and maintain change control in a way that keeps work moving.
• Support regulatory submissions, licence applications and amendments, and responses to regulator questions.
• Support post-market activities, including complaint handling, post-launch monitoring, and trend analysis.
• Support the creation of Device Master Records and the transfer of processes to manufacturing
• Support internal audits, external audits (ex: MDSAP), and interaction with testing laboratories
• Look for ways to simplify and improve the QMS, and challenge processes that add burden without reducing risk
• Collaborate with Subject Matter Experts on process validation activities to ensure consistent, repeatable, and effective processes are implemented during design and manufacturing transfer.
• Maintain and support the development of process control and monitoring to ensure effective process transfer activities and compliance

Skills

Quality concepts

Risk-based decisions

Statistical methods

Cross-functional collaboration

Education

Bachelor's degree in engineering or science

Tools

Python

CAD drawings

Six Sigma

Job description

FluidAI Medical in Kitchener, ON is seeking a Quality Assurance professional to lead the design controls, implement ISO 13485/14971 compliant processes, and collaborate with Engineering, Regulatory, and Operations. The role focuses on risk-based quality, documentation, and regulatory submissions across Canada, the US, and international markets.

You will ensure products meet safety and quality standards, drive CAPA and change control, and support post-market activities while working 50% of the