Quality Engineer

Job Summary:

Do you believe that quality and fast progress can go hand in hand? Do you enjoy solving technical problems in a fast-paced environment? Are you passionate about quality and delivering life-changing medical devices? If so, read on!

At FluidAI, patient safety and regulatory compliance are non-negotiable. We rely on sound judgement and a risk-based approach to meet them effectively, focussing effort where it matters most. You’ll work closely with a cross-functional team to support the development, implementation, and operation of a Quality Management System that is compliant while also being clear, efficient, and scalable. You’ll make sure our controls fit the risk, keep documentation meaningful, and help the team efficiently meet requirements. You’ll also support regulatory activities across Canada, the US, and International markets.

This position requires you to come into our Kitchener, ON office at least 50% of the time.

Job 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 complain 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

Required 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.
• Strong analytical skills with practical knowledge of statistical methods.
• Strong project management skills and the ability to juggle shifting priorities in a fast-moving environment
• Ability to work independently and take ownership.
• Collaborative, solutions-oriented mindset. You help the team find practical, compliant solutions instead of simply flagging problems.
• Ability to work cross-functionally with departments such as Operations, Product Development, Regulatory Affairs, R&D, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Familiarity with cGMP.
• Experience interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).

Preferred Qualifications:

• MASc or MS.
• CQE, CRE, or RAC certifications.
• Experience preparing or supporting regulatory submissions
• Experience interacting with regulators, notified bodies, auditing organizations, and testing laboratories
• Experience with MDSAP audits
• Thorough knowledge of Canadian, US, and International Medical Device Regulations
• Experience assessing changes for regulatory reportability
• Familiarity with post-market surveillance, complaint handling, and adverse event reporting
• Familiarity with IEC 62304 and software as/in a medical device
• Experience building or scaling a QMS at a startup or early-stage company
• Familiarity with Six Sigma and/or Lean manufacturing.
• Applied knowledge of Advanced Quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing/Poka Yoke).
• Experience with the medical device product development lifecycle (risk management, design/process verification, and validation).
• Ability to read and interpret CAD drawings.
• Experience working in compliance risk situations.
• Familiarity with Python or similar programming languages.

Transparency & Hiring Practices:

• Compensation: Salary range for this position is $70,000 - $85,000 CAD annually.
• Application Screening: All applications are screened manually. We do not use AI or AI-Augmented Applicant Tracking Systems (ATS) to screen, assess, reject, or select candidates.
• Position Status: This job posting is for an active vacancy.