Director, Quality Assurance Operations

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 Kardium Inc.'s Quality Assurance (QA) team, and in close collaboration with Executive Management, the Director, QA Operations will be responsible for all the strategic decisions and activities aimed at building the QA infrastructure needed to support product realization operations.

This role will translate corporate strategy directives into set goals and objectives for all QA Operations teams, to ensure quality and business growth requirements are met throughout the entire lifecycle of Kardium's medical device products.

This role will oversee the development, implementation, resourcing, execution, monitoring and improvement of systems and processes for the company's QA operations that support medical device design and development, manufacturing, installation, servicing and change control across the organization's multinational activities.

An individual in this role will also serve as an internal QA Subject Matter Expert to resolve quality issues and promote quality principles and practices across the organization.

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

Responsibilities

• In collaboration with internal stakeholders, including Business Analysis, Information Systems, Operations and Quality Engineering, plan, develop and implement QA operations systems and processes across Kardium's multinational facilities to meet regulatory, production and corporate growth requirements
• Define regional QA Operations goals and objectives in line with corporate strategy directives, and the associated resource needs, including team structure, staffing, and infrastructure, and work with executive management to ensure these needs are met
• Provide leadership to QA Operations Managers and their teams, and oversee regional QA operations to ensure adequate daily QA support is provided to all product realization activities at Kardium
• Formulate, establish and monitor QA Operations metrics, and prepare periodic reports on these metrics for Management Review
• Define, plan and lead the implementation of QMS expansion and process efficiency improvement projects pertaining to QA operations to support corporate growth and maintain product realization compliance.
• Assist with audits and inspections by regulatory agencies and other external parties, and with addressing findings pertaining to QA Operations systems and processes.

Education And Experience

• Bachelor's degree in engineering, natural sciences or similar field. Master's degree preferred
• Minimum of 10 years of progressive QA leadership experience in a manufacturing environment, including QMS planning, implementation, operations and monitoring

• Strong, in-depth working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems for medical devices:

• US FDA (21 CFR parts 820, 801, 803, 806)

• European MDR

• ISO 13485 / MDSAP

• Experience managing multiple teams of QA professionals across several facilities, and able to effectively collaborate with all departments at various levels within a multinational organization

• Experience using quality management tools for process improvement and cost reduction
• Direct organizational development of internal quality policies and practices

Skills And Attributes

• Thorough, in-depth understanding of, and ability to adequately apply, quality assurance, regulatory and compliance concepts and practices in the medical device industry
• Excellent communication skills (written and oral)
• Excellent interpersonal skills, and proven leadership and management skills to motivate and engage teams to work collaboratively and cross-functionally to deliver exceptional results
• Proficient in MS Office
• 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.

• $195,000-$210,000 (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?

• 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.