Compliance Specialist (Hybrid)

Job Responsibility: 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. Kardium has a unique opportunity for a Compliance Specialist. As a member of the Quality Assurance (QA) Team, the Compliance Specialist will provide support to the maintenance of Kardium's Quality Management System (QMS). The position reports to the Director of Compliance and Quality Improvement. 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:

• Acts as a member of the internal audit team performing audits of the QMS system, including assisting with planning, preparing reports, and other audit documentation, and performing follow-up activities
• Performs assessments of investigation, corrective and preventative actions, and effectiveness checks, as needed.
• Performs supplier qualification, monitoring and part certification activities, including site audits
• Assists in the development and delivery of QMS training and other training to employees, to ensure compliance with all applicable standards and regulations
• Assists with development and assessment of QMS performance metrics
• Assists with Document Management activities, as needed. Assists with external audits and regulatory inspections.
• Performs any other QA tasks, as required
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: Education & Experience
• Bachelor's degree, preferably in a technical/science field, or equivalent combination of education and experience
• Three to five years' QA experience in a manufacturing environment
• Strong working knowledge of ISO 13485 and FDA QSR or ISO9001 in a regulated industry
• Experience with electronic document and electronic record management systems
• Previous experience in auditing techniques desirable
Skills
• Strong analytical skills and critical thinking
• Effective written & verbal communication and technical documentation skills
• Excellent computer skills (MS Office, Excel)
• Organized and detail-oriented
• Willingness to travel occasionally.
• Excellent interpersonal skills
• 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 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.
• $70,000 - $94,000 (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!