Quality Assurance Specialist, Engineering (Hybrid)
About The Position
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 obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients! In this role, you will be joining Kardium’s Quality Assurance team. We're looking for experienced QA Specialists who will be at the heart of the action, working directly alongside our Engineering teams to ensure excellence at every step. You'll also play a key role in shaping and improving our Quality Management System (QMS)! You'll work a consistent 5-day week Monday to Friday. Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Requirements
- Bachelor's degree in a technical discipline (e.g., engineering, biotech, pharmaceutical sciences)
- 3+ years of QA experience in biotech or medical device manufacturing
- Strong working knowledge of ISO 13485, FDA QSR, and EU MDD requirements
- Familiarity with document control systems (electronic systems a plus)
- Sharp analytical and critical thinking abilities
- Clear, effective communication—both written and verbal
- Highly organized with strong attention to detail
- Self-directed, yet collaborative across all levels of the organization
- Flexible, adaptable, and solution-oriented
Nice To Haves
- electronic systems a plus
Responsibilities
- Review verification and validation documentation, including but not limited to test plans and reports for equipment qualification, process validation, engineering studies, design verification, engineering change requests, etc.
- Provide QA input into process validation activities
- Conduct the QA review of software tool implementation and validation documentation, such as requirements documents, validation plans, test protocols, test reports, etc.
- Participate in the QA coordination of change control activities
- Execute QA release of incoming materials, in-process goods, and finished products
- Contribute to root cause investigations, process validations, and equipment qualifications
- Participate in internal audits and manage QMS project activities
- Maintain document control in line with Kardium policies and procedures
Benefits
- 5% Retirement Savings Plan contribution
- stock option plan
- Comprehensive medical & dental coverage
- flexible work environment for daily working hours
- 3 personal days per year
- Support for you (and your dependents) overall well-being
- top up for maternity leave, adoptive leave, and parental leave for non-birthing parents
- benefit coverage for fertility drug treatment
- Career progression and learning support
- Professional membership support
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
