POSITION DETAILS:
Job Location: Waterloo
Position Status: New Position
Compensation Range: $65,000.00 - $70,000.00 per year.
AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.
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. Leading OEM navigation platforms rely on our technologies for accuracy and reliability across demanding applications, and as a strategic partner, we support them from concept through integration to commercialization.
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.
THE IMPACT YOU’LL MAKE:
As a Quality Coordinator, you will play an important role in helping ensure our medical device products meet established quality and regulatory requirements before they reach customers. You will collaborate with teams across the organization to support product release, coordinate quality investigations, prepare for audits, and identify opportunities to strengthen our Quality Management System. This is an opportunity to build broad quality experience in a regulated environment while contributing to work that supports product safety, compliance, and customer confidence.
HOW YOU’LL CONTRIBUTE:
- Own day-to-day CAPA management, including intake, coordination, investigation planning, progress monitoring, documentation review, effectiveness verification, and closure coordination in accordance with approved procedures.
- Facilitate cross-functional root cause analysis (RCA), helping teams establish clear problem statements, evaluate objective evidence, and identify underlying causes.
- Coordinate the development of corrective and preventive action plans with designated owners, defined deliverables, due dates, and measurable effectiveness criteria.
- Lead CAPA review meetings, maintain visibility of commitments, follow up with action owners, and escalate overdue activities, resource constraints, and unresolved risks.
- Help ensure products are ready for release by reviewing manufacturing, sterilization, and quality records for completeness and accuracy, resolving documentation gaps, and preparing Certificates of Conformance.
- Monitor product quality by reviewing and trending bioburden results, documenting compliance, and escalating discrepancies or adverse trends for investigation.
- Contribute to audit readiness by preparing plans and supporting evidence, conducting internal audits, documenting findings, and supporting customer and regulatory audits and follow-up activities.
- Strengthen our Quality Management System by maintaining accurate quality records, contributing to quality metrics and management reviews, and improving procedures and work instructions with cross-functional partners.
WHAT YOU’LL BRING:
- A college diploma in engineering, quality, science, or a related technical discipline, or an equivalent combination of education and experience.
- At least three years of hands-on CAPA management experience within a Quality Management System, preferably in a medical device or other regulated environment.
- Demonstrated experience managing CAPA activities from intake through investigation, action implementation, effectiveness verification, and closure.
- Proven ability to facilitate cross-functional RCA and develop clear, evidence-based problem statements and investigation conclusions.
- Familiarity with ISO 13485 or applicable medical device regulatory requirements is an asset.
ADDITIONAL STRENGTHS:
- You bring strong attention to detail, sound judgment, and the ability to organize competing priorities.
- You communicate clearly, work collaboratively, and are comfortable raising quality concerns and following actions through to completion.
- You build collaborative relationships while holding teams accountable for commitments and escalating concerns when needed.
- You approach your work with integrity, curiosity, and a commitment to customer service, continuous improvement, and professional growth.
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, thoughtful problem-solving, and a commitment to doing things right, this could be the place for you. We support one another by building strong partnerships across teams and winning together through shared knowledge and diverse perspectives. You’ll be surrounded by people who are passionate about what they do, continuously learning, improving with purpose, 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. We do not use artificial intelligence or automated decision-making tools in our recruitment process. All applications are reviewed by our hiring team. NDI is committed to providing an inclusive and accessible recruitment process. Accommodations are available upon request for candidates taking part in all aspects of the selection process. If you require accommodation, please let us know and we will work with you to meet your needs. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.
