Work In Tech

At NDI, our mission is built around using our measurement technologies to improve medical procedures and patients’ lives. This requires product innovation that is achieved through fostering collaboration, trust, and strong relationships. At NDI, you will work with talented people who are ready and willing to push their limits in an environment where learning and exploring new ways of doing things is valued as much or more than experience. We are proud of our heritage, culture and international growth over the past 41 years and are honoured to be a valued partner with the world’s leading medical companies.

There's never been a better time to join NDI - The world leader in tracking technology – Join Us!

Role Summary:

The Quality Coordinator plays a critical role in ensuring regulatory compliance of our Quality Management System (QMS) and enhancing customer satisfaction by coordinating various activities as a member of the Quality Systems team. This includes responsibilities for coordination in areas such as Customer Complaints Management, Medical Device Record and Sterile Lot reviews, contributing to improvements in our QMS, while ensuring adherence to regulatory standards. Other activities will include being part of the internal audit team, conducting root cause investigations, and monitoring trends in performance of various processes to highlight areas that need improvement.

Scope of Responsibilities:

• Manage the receipt, evaluation, documentation, investigation, and resolution of customer complaints related to medical devices and non-medical products for our records.
• Communicate with Customer Experience and Quality Engineering for regular status updates on customer complaints.
• Coordinate with internal departments (Customer Experience, Regulatory Affairs, Quality Assurance, Business Managers, RMA, Manufacturing and R&D) to incorporate vital input into complaints.
• Ensure timely processing and closing of complaints to meet Quality Objectives.
• Draft and provide feedback on investigation reports.
• Perform root cause investigations and engage in CAPA (Corrective and Preventive Action) activities.
• Provide material to support post-market surveillance reports.
• Collect complaint case and process metrics to capture and generate trend reports, including RMA data.
• Conduct independent reviews of Sterile Lot records and DHR reviews.
• Lead and/or support other QMS functions as needed, such as Training Management, Document Control, Nonconformances, Deviations, etc.
• Lead and/or support Corrective & Preventive Action (CAPA) program to maintain QMS compliance and drive continuous improvement to our processes.
• Support Computer System Validation (CSV) efforts to maintain software compliance.
• Collaborate with functional process owners to facilitate QMS requirements, continuous process improvements, and audit support.
• Develop and maintain quality procedures, process maps, forms, and other QMS documentation.
• Maintain and apply knowledge of company’s Quality Management System.
• Lead and/or support cross-functional Quality System improvement projects.
• Involved in activities to prepare for customer and regulatory inspections.
• Lead and/or support internal, customer, or 3rd party audits.
• Participate in the NDI internal auditor program.

Quality Requirements:

NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices, and employees of NDI. Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold. Employees of NDI are instrumental to our compliance efforts and are required to understand and comply with the QMS.

As a Quality Coordinator, you are connected to the NDI Quality Management System (QMS) in several ways as defined below.

Proficiency

• Profound understanding of quality principles and apply them effectively and efficiently to quality improvements in all product-related fields.
• Experience in record management preferred.

Competency

• Conducts root cause analyses and identifies appropriate corrective/preventive action plans for supplier-provided components.
• Experience with FDA and ISO 13485 quality management system regulations is recommended.

Education and Professional Qualifications:

• College diploma in engineering or a related field, or equivalent work experience..
• Minimum 1-3 years of experience in Quality Management Systems.

Desired Characteristics/Additional Assets:

• Passion for quality improvement and a Customer FIRST mentality.
• Good communicator and team-player.
• Proactive, systems-minded, problem solver who utilizes quality metrics to drive improvements.
• Eager to learn and develop technical and soft skills.
• Exceptional organizational skills and attentive to detail.
• Working knowledge of Microsoft-base office productivity tools (e.g., Word, Excel, SharePoint).
• Effective written and oral communicator.

Why Choose NDI:

• Generous employer-paid benefits package.
• Company-wide bonus program and annual salary reviews.
• Competitive salary with a Registered Retirement Savings Plan match of up to 4%.
• Employee stock purchase plan.
• It is common in many positions to work in a hybrid model, where flexibility and autonomy are supported by a combination of remote and in-office work.
• Starting at 3 weeks’ vacation plus a company-wide Holiday shut-down in December.
• Employee social and engagement events throughout the year.
• Subsidized professional development and training opportunities.
• A Waterloo Region 2025 Top Employer.
• Growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Close to GRT and ION stops with free on-site parking.

Being a Part of Our Team:

When you walk through our doors, you will find an open-concept office that promotes collaborative teamwork and fresh ideas. We enjoy tackling new challenges and developing new pathways to serve our customers. We are looking for innovative, hard-working individuals who don’t see this as just a job, but as a career choice. If this sounds like you, our HR team would love to hear from you. Follow the instructions below to submit your application.

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.