Quality Assurance Analyst

**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 Assurance Analyst to directly support the integrity and effectiveness of our Quality Management System (QMS). In this role, you will ensure compliance with ISO 13485 and global medical device regulations, maintain the integrity of data in accordance with ALCOA+ and Good Documentation Practices (GDocP), and contribute to data-driven decision-making that drives systemic quality improvements across the organization.

**HOW YOU’LL CONTRIBUTE**:

- Design, run, and maintain QMS trend reports using eQMS data (e.g., CAPA cycle times, nonconformance rates, systemic complaints) to identify systemic weaknesses and guide QA teams in product improvements.
- Support validation and verification activities (IQ/OQ/PQ).
- Perform internal data audits to ensure QMS records are accurate, complete, and audit ready.
- Optimize data collection and reporting tools in collaboration with cross-functional teams.
- Conduct root cause analysis, investigations, and CAPA (Corrective & Preventive Action) activities, including independent reviews of CAPA actions.
- Provide data and materials to support objective analysis and reporting.
- Ensure quality assurance activities comply with ISO 13485 and global medical device regulations, including US FDA 21 CFR Part 820, Health Canada, and EU MDR.
- Collaborate with cross-functional teams to integrate regulatory requirements into quality processes and documentation.

**EDUCATION AND PROFESSIONAL QUALIFICATIONS**:

- Bachelor’s degree in a quantitative field (e.g., Statistics, Engineering, Data Science, Computer Science).
- 2 years or more experience in quality assurance or analytical roles within regulated industries.
- Proficiency with statistical analysis and experience using eQMS software for reporting and trend analysis.

**ADDITIONAL STRENGTHS**:

- Strong analytical and problem-solving skills, with the ability to interpret complex data sets.
- Experience creating data queries and visualizations using tools such as PowerQuery, Power BI, and Excel.
- Excellent communication and collaboration skills across cross-functional teams.
- Commitment to continuous improvement, quality, and regulatory compliance.

**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.