Job Title

OverviewJoin to apply for the Quality and Logistics Technician role at Profound Medical Inc.Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.General AccountabilitySupport the Manufacturing and Quality department as required in all aspects of quality control, quality assurance and logistics activities.Duties and ResponsibilitiesProvide support through receiving, FAI, and inspection of incoming material for conformance to product specification, purchasing specifications, Food and Drug Administration GMPs and ISO 13485Perform timely First Article Inspections and Incoming Inspections using mechanical and measuring equipment to ensure conformance to part/product specifications and requirementsDocument failures thru the NCR process and root cause. Communicate and resolve failures with Suppliers as applicableWrite, review, improve, and create Incoming Inspection plans, first article inspection plans, work instructions, procedures, and special instructions as required based on experience executing plans, NCR results, Corrective Actions and Preventive ActionsPerform logistics activities to support shipments to restock warehouses and to customers. Complete and retain all shipping documentsPrint/review labels for manufacturing as requiredReview process Device History RecordsTrend production quality metricsDevelop and maintain an incoming inspection lab, associated equipment and facilityMaintain control of equipment requiring calibration and preventive maintenance. Coordinate calibration of equipment with manufacturing engineers and procurement team. Coordinate preventive maintenance work with manufacturing engineersPrepare and review shipment of product to sterilizationAssist in In-process/Final Inspection as requiredMay be required to do special testing, engineering support work, and other quality control and quality assurance activitiesActively support quality control and continuous improvement through participation in engineering changes and other improvement programsAdhere to and support the Quality Policy as well as all ISO-13485 Quality System procedures and guidelines;Support Lean activities and initiativesSupport EHS activities and initiativesPerform other duties/special projects as assignedEducation and CertificationCollege or University Degree or at least 3 years of relevant experience.Key AttributesExposure to ISO 9001 quality system minimum. Preferred, exposure to ISO 13485 standardAbility to read and understand part drawings and written specificationsAbility to interpret technical drawings, dimensions, tolerances, etc.Ability to interpret circuit schematicsAbility to create Commercial Invoices, Packing Slips and USMCA formsEmploys a results-oriented work style and teamwork-oriented approach to meeting objectivesDemonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environmentProven ability to establish working relationships with design engineers, sustaining engineers, manufacturing engineers, production technicians, procurement team, QC personnel, and QA personnelWe thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.Referrals increase your chances of interviewing at Profound Medical Inc. by 2x #J-18808-Ljbffr