Arbutus Medical is a rapidly growing medical device venture developing a portfolio of procedure kits to streamline surgery “outside the OR”, starting with orthopaedic trauma procedures in the ER.As we scale, we are strengthening our Quality function to support growth, ensure compliance, and enable efficient product development and commercialization.We are seeking a hands‑on Quality Assurance Lead to own and scale our Quality Management System (QMS) while supporting a critical period of operational growth.This role will play a key leadership role in:Relocating our facility from Vancouver to BurnabyPreparing for and completing our ISO 13485 Surveillance AuditStrengthening quality systems, audit readiness, and regulatory complianceWhat We OfferCompetitive salary (budgeted base salary of $90,000-120,000, depending on experience)An exciting opportunity to get in at the ground floor of a growing ventureFlexible working hours and hybrid arrangementsExtended health benefitsA purpose‑driven workplace with passionate teammates who want to help patients and make a positive difference in the worldKey ResponsibilitiesOwn & Scale the Quality Management System (QMS)Maintain and continuously improve an ISO 13485 / MDSAP‑compliant QMSApply a pragmatic approach: ensuring compliance without unnecessary complexityEnsure audit readiness across:Document controlTraining systems and recordsEquipment and process controlsCAPA and complaint handlingIdentify system gaps and implement scalable, practical solutionsConduct CAPA trend analysis and report insights to leadershipEnsure all quality records are accurate, complete, and audit‑readyFacility TransitionEnsure QMS compliance throughout the facility relocation to BurnabyUpdate documentation, risk assessments, and processes tied to the new sitePartner cross‑functionally with Operations to minimize disruptionSupport validation and readiness of the new facilityAudit & Compliance LeadershipLead preparation for the ISO 13485 surveillance auditAct as the primary QA contact during internal and external auditsSet and track annual quality objectives with senior leadershipPresent KPIs, trends, and quality insights across the organizationProduct & Design QualityDevelop and implement test strategies and validation plansPartner with Engineering to balance speed, compliance,



and practicalityLead Quality Reviews with Operations and Engineering to drive continuous improvementPartner with Supply Chain on supplier qualification, monitoring, and performanceEnsure quality consistency across sterile kits and componentsLead CAPAs and complaint investigations:Root cause analysisCorrective actionsTimely closureSupport new supplier approvals (including regulatory requirements)Requirements5–10+ years in Quality Assurance within medical devices or manufacturing environment(ISO 13485 environment or equivalent)Strong working knowledge of:ISO 13485 or equivalentFDA 21/CFR 820Proven experience with:Audits (internal & external)CAPA systemsQMS ownershipBackground in a technical field (engineering, science, or equivalent)Robust communication skills (including customer‑facing quality discussions)Ability to operate in a fast‑paced, scaling environmentNice‑to‑HaveExperience with MDSAP and/or FDA regulatory requirementsBackground with Class I/II devices, sterile products, or orthopaedicsISO 13485 or ISO 9001 Lead Auditor certificationExperience supporting U.S. regulatory operations (e.G., UDI submissions)Experience supporting or leading facility changes, audits, or scaling environmentsExperience with internationally recognized standards for medical device development (e.G., ISO10993, ISO14971, IEC 60601, ISO 11135, ISO 11137)Desired Capabilities and TraitsHands‑on operator:You execute while thinking strategicallyPragmatic problem solver:You know what’s required vs. what’s unnecessaryDetail‑oriented:You ensure systems hold up under audit scrutinyCross‑functional partner:You build trust across Engineering, Ops, and Supply ChainBalanced mindset:You protect quality without slowing the businessWhy this role, and why now?Arbutus Medical is reinventing how surgery is done outside the OR, starting within the ER, where surgeons struggle with 1M+ bedside procedures a year due to outdated workflows.



We’re building the market’s first portfolio of procedure kit “grab bags” to streamline these procedures, and have launched two FDA‑cleared products to date, TrakPak (to streamline bedside skeletal traction) and SwiftKit (to streamline treatment of fingertip trauma). These are two truly differentiated products that solve practical workflow problems, saving up to 45 min/patient, helping hospitals win back resources and keep staff happy, while improving quality of patient care. We are already in 75+ U.S. hospitals (including more than 20% of all Level 1 Trauma Centers), have a high double‑digit growth rate, and are backed by a deep roster of Canadian healthtech investors. Entering 2026, we are ready to accelerate product development and scale up US sales and medical education to set a new standard of care in our target procedures.Our Commitment to Diversity, Equity, and InclusionArbutus Medical is committed to making diversity, equity, and inclusion part of everything we do, from how we build our products to how we build our workforce. Let us know if we can provide any specific accessibility considerations throughout the interview and candidate screening process.About Arbutus Medical Inc.Arbutus Medical Inc. is a privately held ISO13485 medical device company headquartered in Vancouver, Canada. Arbutus Medical is a medical device innovation engine that streamlines surgical inefficiencies for the good of patient care. The company is currently focused on improving the standard of care for simple orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). Its two leading products are TrakPak, a procedure kit that streamsie bedside skeletal traction, and Digit Revision SwiftKit, a procedure kit that streamlines revision amputations of fingers and toes. In addition, the company has made one of its patented platforms, DrillCover Technology, which adapts DEWALT drills for surgery, available at accessible price points around the globe. The company’s products have regulatory clearances from the U.S. Food & Drug Administration (FDA) and Health Canada, and have been used by customers in 40 countries, enabling an estimated 130,000 surgeries to date. For more information about Arbutus Medical, visit arbutusmedical.Com and follow the company on LinkedIn.#J-18808-Ljbffr

📌 Quality Assurance Lead - C$90,000 - C$120,000 A Year (Winnipeg)
🏢 Arbutus Medical
📍 Winnipeg