Quality Engineering Manager – Post–Market and Services (Hybrid)

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 a Quality Engineering Manager, you will play an instrumental role in our upcoming commercial launch for the Globe® System. You will be responsible for identifying key opportunities for product quality improvement, launch quality engineering initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve technically challenged quality problems. In this role, you will work closely with the Engineering, Manufacturing, Planning, Clinical Engineering, and Risk Management to ensure that Kardium’s cutting-edge medical devices meet high-quality standards.

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:

Service activities:

• Lead the investigation and resolution of service-related quality issues, including root cause analysis, corrective actions, and preventive measures.
• Develop and maintain service manuals and training plans for Service Quality Engineers.
• Develop and implement processes and metrics for tracking and improving service quality performance, including service efficiency, customer satisfaction, and defect rates.
• Provide input into the design, development, and modification of medical devices to ensure serviceability and maintainability, reducing the frequency of repairs and improving overall customer experience.
• Lead and manage a team of Service Quality Engineers, providing coaching and mentoring to ensure high levels of team engagement and productivity.

Post-Market activities:

• Manage post-market surveillance activities, including monitoring and analyzing device-related customer complaints and feedback to identify trends and areas for improvement.
• Lead the investigation of device-related customer complaints, ensuring that root cause analyses are conducted, and corrective and preventive actions (CAPA) are implemented as necessary.
• Lead and manage the post-market quality engineering team, ensuring alignment with company objectives and regulatory requirements.
• Conduct trend analysis on post-market data, identifying potential product quality issues, risks, and opportunities for improvement.
• Collaborate with cross-functional teams, including regulatory affairs, R&D, operations, and customer support, to ensure effective post-market quality management and compliance.
• Provide input to design control activities to enhance product design and performance based on post-market feedback and data.

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:

• A Bachelor of science or engineering degree in biomedical, mechanical, system or applied physics
• At least 7 years of quality engineering experience in a technical, multi-disciplinary environment preferably medical device industry.
• Demonstrated leadership skills and ability to drive results in a timely manner
• Proven experience with root-cause analysis, non-conformances, and other tools typically applied by quality engineers.
• Excellent written and verbal communication skills, especially in a technical context.
• Strong interpersonal skills, with a demonstrated ability to build relationships in the workplace and interface effectively across varying teams and levels of the business.

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.

• $103,000 – 150,000 (CAD Annually)

Your Benefits & Well-being

 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?

1. Our Purpose
2. Our People
3. 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, 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!