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Quality Control Specialist (Onsite)

Kardium Inc.1 day ago
Burnaby, British Columbia, Canada
Mid Level
Full-Time

Top Benefits

Retirement savings plan
Medical coverage
Dental coverage

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 have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients! In this role, you will be joining Kardium’s Quality Control team and working closely with Mechanical Engineering, Risk Management, and Quality Engineering teams to support the development, manufacturing, and sales of Globe® Pulsed Field System. Please note, this opportunity is an onsite work arrangement, located in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities will include: Creating and maintaining QC inspection specifications for Kardium parts in collaboration with the Engineering and Risk Management teams. Applying your knowledge of measurement systems to select appropriate measurement methods for the characteristics specified on engineering drawings. Developing, validating, and qualifying inspection and test methods using Measurement System Analysis (MSA) methodologies, including Gage Repeatability and Reproducibility (Gage R&R). Reviewing and assessing suppliers' First Article Inspection (FAI) documentation for compliance with Kardium requirements. Preparing and maintaining QC technical documentation, including work instructions (WIQs), and standard operating procedures (SOPs). Performing incoming inspections as required.

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's degree in Mechanical Engineering, Biomedical Engineering, Applied Physics, or a related field. At least 3 years of quality experience in a multidisciplinary environment within a regulated industry, including hands-on experience with measurement tools such as calipers, micrometers, imaging systems, and other inspection equipment. Experience developing inspection plans and First Article Inspection Reports (FAIRs) for new products based on mechanical drawings, as well as selecting appropriate measurement tools for each inspection characteristic. Knowledge of Statistical Process Control (SPC), Failure Modes and Effects Analysis (FMEA), Measurement System Analysis (MSA), and Advanced Product Quality Planning (APQP) is considered an asset. Well-developed interpersonal skills with the ability to collaborate effectively across multiple functions and at all levels of the organization. The willingness and ability to take on additional responsibilities as appropriate.

Compensation

Kardium has listed the total cash compensation range (base salary + 5% Retirement Savings Plan 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. $62,000 - $75,000 (CAD Annually) Your Benefits & Well-being The total cash we’ve listed for this position includes a base salary, plus an annual contribution to a Retirement Savings Plan account 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 – we offer a flexible work environment for daily working hours. In addition, we provide 3 personal days per year. Support for you (and your dependents) overall well-being. Family building – we provide top up for maternity leave, adoptive leave, and parental leave for non-birthing parents. 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 ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Irish ERG, Brazilian ERG, and Early Career at Kardium 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!

About Kardium Inc.

Medical Equipment Manufacturing
201-500

Kardium is developing a revolutionary medical device for the diagnosis and treatment of atrial fibrillation.

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