24 Oct
|
NDI (Northern Digital
|
Ontario
24 Oct
NDI (Northern Digital
Ontario
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. As a Quality Coordinator, you will play an significant 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. 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. Lead CAPA review meetings, maintain visibility of commitments, follow up with action owners,
and escalating 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.
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.
Familiarity with ISO 13485 or applicable medical device regulatory requirements is an asset. You communicate clearly, work collaboratively, and are comfortable raising quality concerns and following actions through to completion. You approach your work with integrity, curiosity, and a commitment to customer service, continuous improvement, and professional growth.
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: #
📌 Head of Quality Assurance, Operations (Ontario)
🏢 NDI (Northern Digital
📍 Ontario