Quality Control Specialist (Onsite)
About The Position
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.
Requirements
- 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.
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- 5% Retirement Savings Plan contribution
- Stock option plan
- Comprehensive medical & dental coverage
- Flexible work environment for daily working hours
- 3 personal days per year
- Support for you (and your dependents) overall well-being
- Top up for maternity leave, adoptive leave, and parental leave for non-birthing parents
- Benefit coverage for fertility drug treatment
- Career progression and learning support
- Professional membership support
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
