Quality Specialist

4 weeks ago

Calgary AB, Canada Fluid Biomed Inc. Full time

This is a unique opportunity to join a early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. We are seeking a highly flexible and motivated person for the role of Quality Specialist to join our talented team. Reporting to the Quality Engineer, the Quality Specialist will act as management representative in administrating the elements of the Quality Management System (QMS), lead the quality inspection and supplier quality activities, manage overall inventory, training, and calibration programs, and support the Engineering and Operations team. The role will work within the Quality Department in a fast paced and dynamic environment where attention to detail, ability to multi-task, taking initiatives and collaborating cross-functionally are critical for success.Key Responsibilities include:Own and maintain effective QMS processes and procedures in accordance with ISO 13485 standardsManage company document control activities including revision controls, SOP/document review and approval, document retention and archiving, electronic and hardcopy filing, etc.Maintain Technical documents (Engineering Specifications & Drawings) libraryComplete receiving documentation for incoming parts, components, or equipmentPrepare and lead annual QMS Management Review meetings and present to the team and executivesAct as Management Representative in coordinating regulatory compliance activities/audits with external regulatory affair bodies to obtain and maintain necessary ISO certifications and approvalsUnder ISO 13485 requirements, maintain and execute the internal audit process to assess compliance with QMS requirements and identify areas for improvementsEstablish and maintain key performance indicators (KPIs) to monitor product quality and process effectivenessLead and improve product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholdersInitiate, investigate, and resolve non-conformance reports (NCRs), by implementing corrective and preventive actions (CAPAs) to address root causes of product and process quality issues, and prevent recurrence in a timely mannerOwn and maintain Approved Supplier List (ASL) including qualification, approval, development of quality agreements, and performance evaluation of suppliers in coordination with Engineering teamAssist in the procurement and installation of necessary quality and operational equipment by preparing request for quotes (RFQs), shipping documentation, technical qualification documentation, etc. as requiredMaintain supplier quality documentation including Certificate of Analysis, inspection reports, etc.Execute Non-Disclosure Agreements (NDAs) for external service providers, as requiredManage overall equipment calibration process including maintenance of calibration/maintenance reports, and coordinate ongoing equipment service or testing, in coordination with the Engineering teamManage overall inventory control process including physical and electronic inventory of conforming/non-conforming product, delivery components, and supporting equipmentManage overall training program and maintain training KPI reports, matrix, files, and records for all staffProvide training and education to staff on quality processes, procedures, and regulations as requiredLead and support continuous improvement project activities across the organizationSupport other Quality Department activities as requiredEducation and Experience Requirements:Bachelor’s degree and a minimum of 2 years’ experience with QA/document control in industry requiredExperience working in ISO 9001 or 13485 certified organization requiredDemonstrated experience with Quality Management System, and audit activities requiredExperience or knowledge with root cause analysis techniques requiredGeneral understanding of the training, calibration and inventory processes requiredDemonstrated attention to detail and excellence in written communicationAdditional Skills:Experience as lead resource with document control software preferredCertification as Internal Auditor preferredPrevious R&D/technical industry exposure, able to understand company technology at a practical levelExcellent documentation, communication, and interpersonal relationship skillsStrong problem-solving, organizational, analytical, and critical thinking skillsAbility to navigate uncertainty/fluidity in role scope, priorities, and timelinesAbility to manage competing priorities in a fast-paced and dynamic environmentProven expertise in usage of MS Office SuiteRole is on-site in Calgary, AB and candidates must be legally entitled to work full time in Canada.

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