Quality Assurance Specialist, Production (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 Manufacturing 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 on one of two schedules: Sunday to Thursday or Tuesday to Saturday. Morning shifts starting at 7:00 AM, evening shifts wrapping up around 7:30 PM, and occasional statutory holiday coverage are part of the mix, allowing for weekend flexibility. Premium pay applies for noncore hours worked on Saturday, Sunday, and weekdays after 6:00 PM. 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
Responsibilities
- Review production and engineering documentation, from Device Master Records and DHRs to verification/validation plans, test protocols, and change requests
- Execute QA release of incoming materials, in-process goods, and finished products
- Perform QA review of production documentation associated with quality issues, including deviations, nonconformities, discrepancies, and reworks
- Assist with root cause investigation
- Review software tool implementation and validation documentation
- Conduct the QA review of equipment documentation, including but not limited to qualification, maintenance, and calibration records
- Support QA Operations team members through the review of 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.
- 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
- 3 personal days per year
- Support for well-being (and dependents)
- 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
