QA Team Lead – Equipment and Post- Market Support (Hybrid)
Top Benefits
About the role
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 are now preparing for our upcoming commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a senior member of the Quality Assurance (QA) Operations team, this role takes on main responsibility for complex operational QA tasks and projects, and for the direct QA support to the Manufacturing and Supply Chain teams throughout the product realization lifecycle of sophisticated, high-risk cardiovascular medical devices. This role also provides support to the daily operations of Kardium’s Quality Management System (QMS).
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Additionally, due to the nature of our manufacturing operations, this role involves a rotating or variable schedule. Evening shifts (Eg. Until approximately 7pm) and/or weekend coverage will be part of the responsibilities of this role. Occasional work on statutory holidays may also be required. For candidates selected to interview, this will be discussed in more detail.
Meaningful work you will be a part of:
Clinical and Commercial Support
- Manage (plan, delegate, coordinate and/or execute) the main QA activities that directly support Clinical and Commercial operations, including:
- QA review of production documentation pertaining to customer complaints, including nonconformities, deviation permits, reworks, and any relevant equipment and software records
- QA review of servicing records
- QA review of equipment and software documentation, including qualification, maintenance and calibration records
- QA review of cleanroom monitoring records, including chemical-related activities
- Participate in the QA coordination of change control activities
- Oversee and manage various production priorities assigned to QA as required
- Provide training and mentorship to the QA Operations team
QMS Support
- Participate in Kardium’s Internal Audit program as needed
- Write and review GMP documentation (SOPs, protocols, technical reports, specifications)
- Oversee and manage various QMS project activities assigned to QA
- Assist individuals responsible for managing quality issues by facilitating root cause analysis and advising on corrective and preventive action plans, per Company Standard Operating Procedures and applicable external regulations and standards
- Conduct QA reviews of quality issues in the company’s Problem Report system
- Assist with Document Control tasks such as documentation completeness verification
- Perform any other QA tasks as required such as Manufacturing and Engineering-related support
What we are looking for
Experience and Qualifications:
- Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.).
- At least 6 years' experience in Quality Assurance in a manufacturing environment in the biotech industry, including at least two years’ experience providing leadership to a team of QA professionals.
- Strong, in-depth, working knowledge of ISO 13485, FDA Quality System Regulation (QSR) and QMS requirements of the European Medical Devices Regulation; organizational awareness of QMS implementation and operations
- Thorough knowledge of documentation and record control systems; experience with electronic document and electronic record management systems an asset
Skills and Attributes:
- Strong analytical skills and critical thinking
- Effective written & verbal communication and technical documentation skills
- High proficiency in MS Word/Excel
- Able to operate independently with minimal direction
- Able to work efficiently with the ability to be innovative and to identify creative solution
- Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy and tact
- Ability to work effectively as part of a team and collaborate with staff at all levels
- Flexible and adaptable to take on additional responsibilities as appropriate
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.
- $90,000-$115,000 (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 and 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 and 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
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!
QA Team Lead – Equipment and Post- Market Support (Hybrid)
Top Benefits
About the role
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 are now preparing for our upcoming commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a senior member of the Quality Assurance (QA) Operations team, this role takes on main responsibility for complex operational QA tasks and projects, and for the direct QA support to the Manufacturing and Supply Chain teams throughout the product realization lifecycle of sophisticated, high-risk cardiovascular medical devices. This role also provides support to the daily operations of Kardium’s Quality Management System (QMS).
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Additionally, due to the nature of our manufacturing operations, this role involves a rotating or variable schedule. Evening shifts (Eg. Until approximately 7pm) and/or weekend coverage will be part of the responsibilities of this role. Occasional work on statutory holidays may also be required. For candidates selected to interview, this will be discussed in more detail.
Meaningful work you will be a part of:
Clinical and Commercial Support
- Manage (plan, delegate, coordinate and/or execute) the main QA activities that directly support Clinical and Commercial operations, including:
- QA review of production documentation pertaining to customer complaints, including nonconformities, deviation permits, reworks, and any relevant equipment and software records
- QA review of servicing records
- QA review of equipment and software documentation, including qualification, maintenance and calibration records
- QA review of cleanroom monitoring records, including chemical-related activities
- Participate in the QA coordination of change control activities
- Oversee and manage various production priorities assigned to QA as required
- Provide training and mentorship to the QA Operations team
QMS Support
- Participate in Kardium’s Internal Audit program as needed
- Write and review GMP documentation (SOPs, protocols, technical reports, specifications)
- Oversee and manage various QMS project activities assigned to QA
- Assist individuals responsible for managing quality issues by facilitating root cause analysis and advising on corrective and preventive action plans, per Company Standard Operating Procedures and applicable external regulations and standards
- Conduct QA reviews of quality issues in the company’s Problem Report system
- Assist with Document Control tasks such as documentation completeness verification
- Perform any other QA tasks as required such as Manufacturing and Engineering-related support
What we are looking for
Experience and Qualifications:
- Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.).
- At least 6 years' experience in Quality Assurance in a manufacturing environment in the biotech industry, including at least two years’ experience providing leadership to a team of QA professionals.
- Strong, in-depth, working knowledge of ISO 13485, FDA Quality System Regulation (QSR) and QMS requirements of the European Medical Devices Regulation; organizational awareness of QMS implementation and operations
- Thorough knowledge of documentation and record control systems; experience with electronic document and electronic record management systems an asset
Skills and Attributes:
- Strong analytical skills and critical thinking
- Effective written & verbal communication and technical documentation skills
- High proficiency in MS Word/Excel
- Able to operate independently with minimal direction
- Able to work efficiently with the ability to be innovative and to identify creative solution
- Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy and tact
- Ability to work effectively as part of a team and collaborate with staff at all levels
- Flexible and adaptable to take on additional responsibilities as appropriate
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.
- $90,000-$115,000 (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 and 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 and 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
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!