Every day, your work supports the advancement of medical technology. NDI is the recognized global leader and industry pioneer of Optical and Electromagnetic tracking technology. Backed by decades of innovation and expertise, we're the strategic partner of choice for the world's top medical device OEMs, advancing the development of OEM navigation platforms.

Whether you're designing technology, supporting customers, or enabling the teams behind them, your work matters. Every role at NDI plays a part in shaping the future of medical technology innovation.

Senior Quality Engineering Specialist

Reporting to the Senior Manager, Quality Assurance & Regulatory Affairs, the Senior Quality Engineering Specialist-Medical Device plays a key role in ensuring NDI products meet global regulatory requirements. In this role, you will support the full product lifecycle, including development, commercialization, and post market performance of medical devices. This role ensures products meet safety, performance, and regulatory requirements through the application of risk-based quality engineering principles and robust quality systems.

You will act as a key quality partner across R&D;, manufacturing, and regulatory teams, driving design quality, leading investigations, and ensuring compliance with ISO 13485, FDA QSR, and global regulatory requirements. Lead quality engineering activities across the product lifecycle, including design, transfer, and post market support. Lead risk management activities (FMEA, hazard analysis) in accordance with ISO 14971.

Own and drive complex investigations, including complaints, nonconformances, MRB, CAPAs and SCARs.



Analyze field performance and quality data to identify systemic issues and lead improvement initiatives. Review and approve quality documentation including DHF, DMR, DHR, and technical files.

Support regulatory inspections and external audits (FDA, ISO, MDSAP). Support process validation and manufacturing quality activities including sterilization and packaging. Collaborate with cross-functional teams to ensure quality is embedded in design and production.

Support supplier quality activities, including qualification and audits. Drive continuous improvement initiatives to enhance product quality and compliance. Bachelor’s degree in Engineering, Biomedical Engineering, or related field (or equivalent experience). ~9+ years of experience in quality engineering within a regulated industry (medical device preferred). ~ Working towards or certified as a Certified Quality Engineer.

ISO 13485:2016 Lead Auditor Certification an asset. Risk management (ISO 14971). Design controls and validation.

Experience with CAPA, NCR, complaints handling, and audits. Competitive pay with a 4% RRSP match to help you plan for the future. Company-wide bonus program and regular salary reviews.

Employee Stock Purchase

Plan offering discounted company shares to help you invest in and benefit from our growth. Receive 15 vacation days starting on day one,



plus a paid holiday shutdown in December to recharge before the New Year! A calendar full of employee social events and engagement activities to keep us connected.

Professional and personal development support designed to foster your continuous growth and career advancement. Conveniently located near GRT and ION transit stops, with free on-site parking available. We support one another by building strong partnerships across teams and winning together through shared knowledge and diverse perspectives.

We do not use artificial intelligence or automated decision-making tools in our recruitment process. Accommodations are available upon request for candidates taking part in all aspects of the selection process. For more information about NDI and this position, please visit our website: NDI is proud to be an equal prospect employer and does not unlawfully discriminate against any employee or applicant on the basis of race, color, religion, sex, place of origin, ancestry, age, ethnic origin, sexual orientation, citizenship, creed, family status, handicap or marital status.

NDI is committed to minimizing barriers to persons with disabilities. We are committed to aligning our policies, practices, and procedures with The Accessibility for Ontarians with Disabilities Act, 2005 (AODA) by identifying, removing, and preventing barriers to inclusion for people with disabilities. We continually monitor and evaluate the implementation of NDI's Accessibility Plan and Accessibility Policy, and solicit feedback related to NDI's accessibility initiatives from employees and customers alike. #

📌 Senior Quality Engineer/Technician (Ontario)
🏢 Northern Digital
📍 Ontario