Senior Business Analyst - Quality Assurance (Hybrid)

Kardium Inc.; Burnaby; Hybrid; CAD 95,000 - 145,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Senior Business Analysten für Qualitätsmanagement und Compliance. In dieser spannenden Rolle werden Sie die Implementierung von ERP und QMS unterstützen, um sicherzustellen, dass die Qualitätsprozesse mit dem rasanten Wachstum des Unternehmens Schritt halten. Ihre Expertise wird entscheidend sein, um die Einhaltung regulatorischer Anforderungen zu gewährleisten und die Effizienz der Betriebsabläufe zu optimieren. Wenn Sie leidenschaftlich an der Verbesserung von Qualitätsstandards in der Medizintechnik interessiert sind, ist dies die perfekte Gelegenheit für Sie, einen bedeutenden Einfluss auf die Branche zu haben.

Benefits

Umfassende medizinische und zahnärztliche Versorgung

Flexibilität bei der Arbeitszeit

3 persönliche Tage pro Jahr

Karriereentwicklung und Lernunterstützung

Unterstützung für berufliche Mitgliedschaften

Familienförderung für Mutterschafts- und Adoptionsurlaub

Qualifications

• Starke Kenntnisse im Qualitätsmanagement und regulatorischen Angelegenheiten.
• Erfahrung in der Implementierung von ERP- und QMS-Systemen.

Responsibilities

• Engagement mit QA- und Fertigungsteams zur Verbesserung der Prozesse.
• Dokumentation und Analyse von Qualitätsprozessen zur Identifizierung von Lücken.

Skills

Qualitätsmanagement

Regulatorische Angelegenheiten

Prozessoptimierung

Stakeholder-Management

Projektmanagement

Education

Bachelorabschluss

Zertifizierung als Qualitätsprüfer (CQA)

Zertifizierung als Qualitätsingenieur (CQE)

Tools

Microsoft Dynamics 365

MasterControl

Job description

Senior Business Analyst - Quality Assurance (Hybrid)

Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada Req #254

March 26, 2025

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.

As the Senior Business Analyst – Quality Assurance (QA) & Compliance, you will be instrumental in the successful implementation and optimization of ERP, QMS (Quality Management System), and other business applications, ensuring alignment with quality, regulatory, and compliance requirements. This role is critical in ensuring that our quality processes scale with our rapid growth, supporting the business in maintaining high standards for product quality, compliance, and operational efficiency.

You will be expected to develop a deep understanding of our current QA processes and systems, actively engaging with stakeholders across quality, manufacturing, and regulatory teams. Your insights will help drive system enhancements, process improvements, and seamless integration of quality management into our broader business applications.

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

Meaningful work you will be a part of

Your responsibilities will include:

• Develop Deep Business & System Knowledge – Engage with QA, regulatory, and manufacturing teams to understand existing processes, systems, and compliance requirements.
• Business Requirements & Process Mapping – Document and analyze quality processes, identifying gaps and translating business needs into functional system requirements.
• ERP & QMS Integration – Support the implementation of Microsoft Dynamics 365, MasterControl, and other quality systems, ensuring seamless data flow and compliance tracking.
• Stakeholder Engagement & Communication – Act as a liaison between QA, IT, operations, and external partners, ensuring alignment of quality requirements with business objectives.
• Regulatory & Compliance Support – Ensure system configurations and process changes adhere to ISO, FDA, Health Canada, and other industry regulations.
• Testing & Validation – Develop test cases, support validation activities, and ensure compliance with GxP, CFR Part 11, and other industry standards.
• Change Management & Training – Drive adoption of new QA processes and systems by supporting training initiatives and providing clear documentation.
• Roadmap & Continuous Improvement – Help define the long-term strategy for quality systems, identifying opportunities to enhance compliance, automation, and efficiency.

What you bring to the team

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.

You will be successful in this role because you possess these attributes:

• QA & Compliance Expertise – Strong background in quality management, compliance, and regulatory affairs, with experience in medical devices, pharmaceuticals, or other regulated industries.
• Experience in Complex Industries – Familiarity with complex manufacturing environments, particularly those with stringent regulatory requirements.
• Engineering or Technical Acumen – Either an engineering background or strong experience working in an engineering-driven organizations, particularly in quality and compliance.
• Strong Knowledge of QA Systems – Experience with QMS platforms, ERP systems, and compliance tracking tools.
• Proactive Business Engagement – A hands-on approach to learning and understanding current QA processes, ensuring solutions align with real-world operational challenges.
• Regulatory & Compliance Knowledge – Deep understanding of quality standards, and experience with document control, CAPA management, and electronic batch records.
• Business & IT Alignment – Ability to bridge the gap between quality teams, IT, and business leaders, ensuring smooth system implementations.
• Process Optimization & Automation – Experience identifying opportunities to streamline quality processes through system enhancements and automation.
• Excellent Communication & Stakeholder Management – Ability to engage with senior leadership, QA teams, and IT professionals to drive alignment and project success.
• Project Management & Change Leadership – Comfortable managing multiple priorities, leading workshops, and facilitating the adoption of new processes and technologies.
• Relevant Certifications & Tools – Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or CBAP (Certified Business Analysis Professional) are a plus.

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 withmore 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.

• $95,000 - $145,000 (CAD Annually)

Total cash – 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.

Career progression and learning support.

Professional membership support.

Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.

Life at Kardium

What makes us a great place to work?

• Our Purpose
• Our People
• Our Culture

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, Brazilian 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!

• Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada