Manager, Commercial QA

Posted Friday, February 28, 2025 at 11:00 a.m.

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.

Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe Pulsed Field System – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.

Kardium has a unique opportunity for a Manager, Commercial QA. As a member of the Quality Assurance (QA) Team, the Manager, Commercial QA will be responsible for implementing, managing and improving Kardium’s Complaint Handling System in accordance with applicable global regulations and requirements, including 21 CFR Part 820, ISO 13485:2016, Canadian Medical Devices Regulations, and EU MDR. This role will work in close collaboration with Customer Service and Field Service groups to process all customer issues and to identify customer complaints and will maintain all complaint and complaint investigation files according to Kardium’s Quality Management System requirements.

This person will work with stakeholder departments such as Engineering, Quality Engineering, Supply Chain, Clinical Affairs, Clinical Engineering and Regulatory Affairs on Post Market Surveillance strategy and execution. This role will also lead the CAPA Review Board and provide support to the maintenance of Kardium’s Quality Management System (QMS). The position reports to the Director of Compliance and Quality Improvement.

Please note, this opportunity is a Hybrid work arrangement, located in Burnaby, BC.

What you’ll be doing

Your responsibilities will include:

• Implement and Maintain Kardium’s Complaint Handling System.
• Monitor Complaint handling system to identify process improvement to enhance surveillance and increase efficiency.
• Oversee medical device complaint processing at Kardium, in compliance with applicable regulations and standards, including FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations, and the European Medical Device Regulation.
• Ensure Kardium staff receive adequate training to identify and report complaints in a timely fashion.
• Manage the timely in-flow and triaging of customer complaints, assignment of investigation responsibilities, and expedient processing and closure of complaints to meet quality objectives. Ensure complaints are properly documented and evaluated for MDR and Vigilance Reporting.
• Establish and maintain Quality Data Metrics related to Complaints, CAPAs, and other QMS processes as assigned
• Analyze and interpret quality system performance metrics and prepare reports for PMS and Management Review
• Develop and provide leadership to the Commercial QA team
• Lead CAPA Review Board to facilitate processing and closure of open CAPAs, and review CAPA extensions and escalations
• Perform any other QA tasks as required, including but not limited to:
• Leading root cause investigations and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts
• Conducting Internal Audits to assess the compliance of quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP
• Participating in external audits and regulatory inspections

What you bring to the team

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We…