Quality Systems Analyst
Top Benefits
About the role
Quality Systems Analyst
Location: Waterloo, Ontario
Employment Type: Full-Time - Regular
Position Vacancy Type: Newly created position.
Compensation Range: $80,000.00 - $100,000.00 per year
AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.
Every day, we help shape the future of healthcare. We design and build 3D tracking systems that equip medical devices with advanced spatial navigation technology, delivering greater accuracy, performance, and confidence in procedures where precision is critical. Since 1981, we’ve partnered with leading OEMs and research institutes to push the boundaries of surgical navigation. Our optical and electromagnetic technologies are trusted in procedures ranging from orthopaedics and spine surgery to cardiac interventions and radiation therapy.
Whether you're designing systems, supporting customers, or enabling the teams behind them, your work matters. It brings clarity to healthcare and helps improve outcomes for patients around the world.
THE IMPACT YOU’LL MAKE:
We are seeking a detail-oriented Quality Systems Analyst to directly support the integrity and effectiveness of our Quality Management System (QMS). You will own our Data Integrity Audit Program and serve as the primary analytics expert who turns QMS signals into audit-ready CAPA insights and verified process improvements. In this role, you will lead data-driven, cross-functional investigations, deliver high-integrity analytics that demonstrate CAPA effectiveness, and drive systemic improvements across the organization.
HOW YOU’LL CONTRIBUTE:
- Lead data integrity audits across our QMS processes, systems, and analytical pipelines.
- Design, maintain, and automate audit-ready QMS analytics, dashboards, and trend reports using eQMS data and analytical tools (e.g., Excel, PowerQuery, Power BI).
- Apply statistical process control (SPC), statistical techniques, and data modeling to identify systemic quality risks and improvement opportunities.
- Lead and support investigations for CAPA, complaints, and other quality system elements.
EDUCATION AND PROFESSIONAL QUALIFICATIONS:
- 7+ years QA/QMS or regulated-industry analytics experience, or equivalent combination of education and relevant experience.
- Medical device background strongly preferred, ISO 13485 and global medical device regulations, including Health Canada, US FDA 21 CFR Part 820, and EU MDR.
- Bachelor’s degree in a quantitative field (e.g., Statistics, Engineering, Data Science, Computer Science).
ADDITIONAL STRENGTHS:
- Proven ownership of data integrity audits or comparable programs; clear experience applying ALCOA+ and good documentation practices (GDocP).
- Expert PowerQuery / Excel + Power BI analytics and SPC experience
- Experience supporting IQ/OQ/PQ validation and data-driven CAPA verification
THE BENEFITS OF JOINING OUR TEAM
- Competitive pay with a 4% RRSP match to help you plan for the future.
- A comprehensive benefits package that supports your health and well-being.
- 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.
- A 37.5-hour work week with a hybrid work model available where responsibilities allow.
- 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.
- Work where your contributions are valued — as a multi-year winner of Waterloo Region’s Top Employers and the 2025 Chamber of Commerce Business of the Year, we’re recognized for putting people first and fostering a culture of collaboration and excellence.
- Part of a growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
- Conveniently located near GRT and ION transit stops, with free on-site parking available.
If you’re looking to join a collaborative and curious team—guided by integrity, bold thinking, and a commitment to doing things right—this could be the team for you. We believe in supporting one another and working together to find creative solutions. You’ll be surrounded by people who are passionate about what they do and driven by work that truly makes a difference. If this sounds like the right fit for you, we invite you to apply online and introduce yourself.
We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.
About NDI (Northern Digital Inc.)
NDI is a global authority in optical and electromagnetic (EM) navigation technology for the medical device market. Fast and accurate medical device tracking is essential to preserving optimal workflow while adding to procedure efficacy and clinician confidence.
Our technology has been seamlessly integrated into numerous medical applications, including but not limited to surgical robotics, electrophysiology, neuro, spine, interventional radiology, transcranial magnetic stimulation, ENT, and orthopedics.
Our optical and EM navigation solutions integrate into OEM medical devices, providing real-time instrument navigation in a broad range of applications. Backed by over 40 years of industry expertise and innovation, NDI manufactures the most accurate and responsive optical navigation solutions alongside gold standard EM navigation solutions that track sensor embedded OEM instruments without a line of sight.
Navigate new possibilities with NDI, your trusted and reliable navigation technology partner.
Quality Systems Analyst
Top Benefits
About the role
Quality Systems Analyst
Location: Waterloo, Ontario
Employment Type: Full-Time - Regular
Position Vacancy Type: Newly created position.
Compensation Range: $80,000.00 - $100,000.00 per year
AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.
Every day, we help shape the future of healthcare. We design and build 3D tracking systems that equip medical devices with advanced spatial navigation technology, delivering greater accuracy, performance, and confidence in procedures where precision is critical. Since 1981, we’ve partnered with leading OEMs and research institutes to push the boundaries of surgical navigation. Our optical and electromagnetic technologies are trusted in procedures ranging from orthopaedics and spine surgery to cardiac interventions and radiation therapy.
Whether you're designing systems, supporting customers, or enabling the teams behind them, your work matters. It brings clarity to healthcare and helps improve outcomes for patients around the world.
THE IMPACT YOU’LL MAKE:
We are seeking a detail-oriented Quality Systems Analyst to directly support the integrity and effectiveness of our Quality Management System (QMS). You will own our Data Integrity Audit Program and serve as the primary analytics expert who turns QMS signals into audit-ready CAPA insights and verified process improvements. In this role, you will lead data-driven, cross-functional investigations, deliver high-integrity analytics that demonstrate CAPA effectiveness, and drive systemic improvements across the organization.
HOW YOU’LL CONTRIBUTE:
- Lead data integrity audits across our QMS processes, systems, and analytical pipelines.
- Design, maintain, and automate audit-ready QMS analytics, dashboards, and trend reports using eQMS data and analytical tools (e.g., Excel, PowerQuery, Power BI).
- Apply statistical process control (SPC), statistical techniques, and data modeling to identify systemic quality risks and improvement opportunities.
- Lead and support investigations for CAPA, complaints, and other quality system elements.
EDUCATION AND PROFESSIONAL QUALIFICATIONS:
- 7+ years QA/QMS or regulated-industry analytics experience, or equivalent combination of education and relevant experience.
- Medical device background strongly preferred, ISO 13485 and global medical device regulations, including Health Canada, US FDA 21 CFR Part 820, and EU MDR.
- Bachelor’s degree in a quantitative field (e.g., Statistics, Engineering, Data Science, Computer Science).
ADDITIONAL STRENGTHS:
- Proven ownership of data integrity audits or comparable programs; clear experience applying ALCOA+ and good documentation practices (GDocP).
- Expert PowerQuery / Excel + Power BI analytics and SPC experience
- Experience supporting IQ/OQ/PQ validation and data-driven CAPA verification
THE BENEFITS OF JOINING OUR TEAM
- Competitive pay with a 4% RRSP match to help you plan for the future.
- A comprehensive benefits package that supports your health and well-being.
- 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.
- A 37.5-hour work week with a hybrid work model available where responsibilities allow.
- 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.
- Work where your contributions are valued — as a multi-year winner of Waterloo Region’s Top Employers and the 2025 Chamber of Commerce Business of the Year, we’re recognized for putting people first and fostering a culture of collaboration and excellence.
- Part of a growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
- Conveniently located near GRT and ION transit stops, with free on-site parking available.
If you’re looking to join a collaborative and curious team—guided by integrity, bold thinking, and a commitment to doing things right—this could be the team for you. We believe in supporting one another and working together to find creative solutions. You’ll be surrounded by people who are passionate about what they do and driven by work that truly makes a difference. If this sounds like the right fit for you, we invite you to apply online and introduce yourself.
We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.
About NDI (Northern Digital Inc.)
NDI is a global authority in optical and electromagnetic (EM) navigation technology for the medical device market. Fast and accurate medical device tracking is essential to preserving optimal workflow while adding to procedure efficacy and clinician confidence.
Our technology has been seamlessly integrated into numerous medical applications, including but not limited to surgical robotics, electrophysiology, neuro, spine, interventional radiology, transcranial magnetic stimulation, ENT, and orthopedics.
Our optical and EM navigation solutions integrate into OEM medical devices, providing real-time instrument navigation in a broad range of applications. Backed by over 40 years of industry expertise and innovation, NDI manufactures the most accurate and responsive optical navigation solutions alongside gold standard EM navigation solutions that track sensor embedded OEM instruments without a line of sight.
Navigate new possibilities with NDI, your trusted and reliable navigation technology partner.