Quality Engineer Manager – Complaints Investigations (Hybrid)

Kardium Inc.; Burnaby; Hybrid; CAD 105,000 - 131,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Quality Engineer Manager, um die Qualitätssicherung für medizinische Geräte zu leiten. In dieser spannenden Rolle arbeiten Sie eng mit Engineering, Fertigung und klinischen Teams zusammen, um Produktbeschwerden zu bearbeiten und Verbesserungsmöglichkeiten zu identifizieren. Sie werden die Verantwortung für die Einhaltung von Standards und die Durchführung von Untersuchungen übernehmen, während Sie ein Team von Fachleuten leiten. Diese Position bietet die Möglichkeit, einen bedeutenden Einfluss auf die Patientenversorgung zu haben und Teil eines dynamischen, unterstützenden und inklusiven Arbeitsumfelds zu sein.

Benefits

Aktienoptionen

Umfassende medizinische und zahnärztliche Versorgung

Berufliche Entwicklung

Familienunterstützung

Flexibilität bei der Arbeit

Qualifications

• 5+ Jahre Erfahrung im Qualitätsengineering in regulierten Umgebungen.
• Mindestens 2 Jahre Erfahrung in einer Führungsposition.

Responsibilities

• Leitung des Beschwerdeuntersuchungsteams und Sicherstellung der Compliance.
• Koordination der Untersuchung von Beschwerden über Globe-Produkte.

Skills

Qualitätsengineering

Regulatorische Standards

Kommunikationsfähigkeiten

Technische Dokumentation

Education

Bachelor in Biomedizintechnik

Bachelor in Maschinenbau

Bachelor in Physik

Tools

ISO 13485

US FDA QSR

Job description

Quality Engineer Manager – Complaints Investigations (Hybrid)

Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada Req #249

March 18, 2025

Your opportunity

Join Kardium to make a difference in patients' lives with our innovative medical device for atrial fibrillation diagnosis and treatment. Our mission is to deliver the best treatment for atrial fibrillation, supported by our advanced Globe Pulsed Field System and a dedicated technical team. We are now focusing on regulatory approvals and market launch following our pivotal clinical study.

Role Overview

As part of the Quality Engineering team, collaborating closely with Engineering, Manufacturing, and Clinical teams, the Quality Engineer Manager – Complaints Investigations will oversee the processing of product quality complaints, lead investigations, and identify opportunities for product improvement. This role is based in Burnaby, BC, with a hybrid work arrangement.

Key Responsibilities

1. Lead and manage the complaint investigation team, ensuring compliance with company and regulatory standards.
2. Work with Quality Assurance to develop and refine complaint intake and documentation systems.
3. Coordinate triaging and investigation of complaints related to Globe products, including testing, root cause analysis, and CAPA implementation.
4. Ensure timely and adequate documentation of investigations and corrective actions.
5. Manage post-market surveillance activities, analyzing feedback for trends and improvements.
6. Contribute to design control activities to enhance product performance based on field data.

Candidate Profile

Our team values innovation, collaboration, and passion for medical device development. Success in this role requires:

• Bachelor’s degree in biomedical, mechanical, systems engineering, or physics.
• At least 5 years of quality engineering experience in a regulated, multidisciplinary environment, including 2 years in a managerial role.
• Leadership skills with a proven ability to drive results.
• Experience with ISO 13485 and US FDA QSR is preferred.
• Strong communication and technical documentation skills.
• Excellent interpersonal skills across functions and organizational levels.

Compensation & Benefits

Salary range: $105,000 - $131,000 CAD annually, including base salary and 5% RRSP contribution. Employees are eligible for stock options, comprehensive medical and dental coverage from Day 1, work flexibility, family support, professional development, and inclusive culture initiatives.

Work Environment

We foster a diverse and inclusive workplace, supporting ERGs and accommodating individual needs throughout the recruitment process. Learn more about us on Glassdoor.