Quality Coordinator

NDI (Northern Digital Inc.); Southwestern Ontario; On-site; CAD 65,000 - 70,000; Full time

Benefits offered by this job

4% RRSP match

Comprehensive benefits package

Employee Stock Purchase Plan

37.5-hour work week with hybrid model

15 vacation days from day one

Job summary

Northern Digital Inc. (NDI) is seeking a Quality Coordinator in Waterloo to help ensure our medical device products meet quality and regulatory requirements before release. You will collaborate across teams to support product release, investigations, audits, and quality system improvements.

You will build broad quality experience in a regulated environment, contributing to product safety, compliance, and customer confidence, with a 37.5-hour week and a hybrid work model where feasible.

Qualifications

• At least three years of hands-on CAPA management experience within a Quality Management System.
• 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.

Responsibilities

• Own day-to-day CAPA management, including intake, coordination, investigation planning, progress monitoring, documentation review, effectiveness verification, and closure coordination.
• Facilitate cross-functional root cause analysis (RCA) to establish problem statements and identify underlying causes.
• Coordinate development of corrective and preventive action plans with owners, due dates, and measurable criteria.
• Lead CAPA review meetings, track commitments, and escalate overdue activities and risks.
• Review manufacturing, sterilization and quality records to ensure readiness for release and prepare Certificates of Conformance.
• Monitor product quality by reviewing bioburden results and escalate discrepancies.
• Prepare plans and evidence for internal and customer/regulatory audits.

Skills

CAPA management

Root cause analysis

CAPA plans

Quality records

Cross-functional collaboration

Education

College diploma in engineering/quality/science

Job description

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.

Quality Coordinator

POSITION DETAILS:

Job Location: Waterloo

Position Status: New Position

Compensation Range: $65,000.00 - $70,000.00 per year.

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 elevate 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.

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. For more information about NDI and this position, please visit our website: www.ndigital.com.

NDI is proud to be an equal opportunity employer and does not unlawfully discriminate against any employee or applicant on the basis of race, color, religion, sex, place of origin, ancestry, age, ethnic origin, sexual orientation, citizenship, creed, family status, handicap or marital status. We believe in the dignity and worth of all individuals and promote inclusivity and accessibility in how we do business. NDI is committed to minimizing barriers to persons with disabilities. NDI’s Statement of Commitment and multi-year accessibility plan is accessible upon request by e‑[e-mail].

Accessibility

At NDI we believe in the dignity and worth of all individuals and promote inclusivity and accessibility in all aspects of how we operate. We are committed to aligning our policies, practices, and procedures with The Accessibility for Ontarians with Disabilities Act, 2005 (AODA) by identifying, removing, and preventing barriers to inclusion for people with disabilities. We continually monitor and evaluate the implementation of NDI’s Accessibility Plan and Accessibility Policy, and solicit feedback related to NDI’s accessibility initiatives from employees and customers alike.