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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.