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 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.