Coordinate CAPA management at NDI, supporting medical device quality through root cause analysis and evidence-based investigations. Hybrid work may be available where responsibilities allow.
As a Quality Coordinator, you will support product release, quality investigations, audit readiness, and Quality Management System improvements. You will work across teams in a regulated medical device environment, coordinating corrective and preventive actions from intake through closure. Your work helps ensure products meet established quality and regulatory requirements before reaching customers.
Key Responsibilities:
- Coordinate CAPA intake, investigations, documentation, verification, and closure
- Facilitate cross-functional root cause analysis using objective evidence
- Lead CAPA reviews and escalate overdue activities, constraints, and risks
- Coordinate corrective and preventive action plans and effectiveness criteria
- Maintain visibility of commitments and follow up with action owners
Requirements:
- College diploma in engineering, quality, science, or related technical discipline
- At least three years of hands-on CAPA management experience
- Experience managing CAPA from intake through effectiveness verification and closure
- Ability to facilitate cross-functional root cause analysis
- Familiarity with ISO 13485 is an asset
Apply CAPA coordination, investigation planning, and root cause analysis skills to support NDI's medical device quality systems.
Quality Coordinator CAPA Management in Alton employer: NDI (Northern Digital Inc.)
At NDI, we pride ourselves on being an exceptional employer that champions innovation and collaboration in the healthcare sector. Our dynamic work culture fosters professional growth and empowers employees to make a meaningful impact in transforming healthcare through cutting-edge device solutions. With a commitment to employee development and a focus on strategic initiatives, NDI offers a unique opportunity for leaders to thrive in a supportive environment while driving sustainable revenue and enhancing customer engagement.
Contact Details:
NDI (Northern Digital Inc.) Recruitment Team
