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Kardium Inc. is seeking a Manager, Commercial QA to oversee its Complaint Handling System, ensuring compliance with global medical device regulations. The successful candidate will lead a team, improve processes, and collaborate across departments to uphold quality standards essential for successful product launches.
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:
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 work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.
You will be successful in this role because you possess these attributes:
Compensation
Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.
As a permanent employee, you will also participate in Kardium’s stock option plan.
The total cash we’ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.
Comprehensive medical & dental coverage for all permanent employees – effective as of Day 1, with no waiting period.
Work-day flexibility – additionally, we provide 3 personal days per year.
Support for you (and your dependents) overall well-being.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Career progression and learning support.
Professional membership support.
Life at Kardium
What makes us a great place to work?
Our Purpose
Our People
Our Culture
Brilliant
Achievers
Communication
Quality
Trust
Decision making
At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.
We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, and Irish ERG.
As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.
And our employees think we are great too – check out Glassdoor to learn more!