Quality Engineer Manager – Complaints Investigations (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 part of the Quality Engineering team, and in close cooperation with the Engineering, Manufacturing and Clinical teams, the Quality Engineer Manager – Complaints Investigations ensures that Kardium’s cutting-edge medical devices meet high-quality standards. In this role, you will plan, optimize and manage the systems and activities required to process product quality complaints received from the field, lead investigations, identify key opportunities for product quality improvement, and launch quality engineering initiatives. 

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:

• Lead and manage the complaint investigation team, ensuring alignment with company objectives and regulatory requirements. 

• Collaborate with Quality Assurance to develop and optimize Kardium’s complaint in-take system for documenting investigations and reportability of issues discovered during use of Globe® products in the field.  

• Plan, coordinate and perform the triaging of all complaints related to Globe® products and procedures that are reported during use in the field.  

• Lead the investigation of product-related complaints, coordinating testing and inspection of devices returned from the field, ensuring that root cause analyses are conducted, and corrective and preventive actions (CAPA) are implemented as necessary. 

• Ensure that all internal documentation for investigations and corrective actions for reported field issues is completed adequately and in a timely fashion to ensure compliance. 

• Manage post-market surveillance activities, including monitoring and analyzing product-related complaints and feedback to identify trends and areas for improvement. 

• 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 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:

• Bachelor of science or engineering degree in biomedical, mechanical, system or applied physics.  

• At least 5 years of quality engineering experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices, including 2 years in a managerial capacity.  

• Demonstrated leadership skills and ability to drive results in a timely manner.  

• Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation is desired.  

• Proven written and verbal communication and technical documentation skills.  

• Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization.  

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.

• $105,000 - $131,000 (CAD Annually)

Your Benefits & Well-being

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?

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, 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!