Quality Assurance Lead - Arbutus Medical Systems

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 Burnaby Preparing for and completing our ISO 13485 Surveillance Audit Strengthening quality systems, audit readiness, and regulatory compliance As the first hire with sole QA responsibility, this high-impact, high-visibility role will play a key role in structuring our systems for growth. This role is well-suited for someone who can execute while thinking at a systems level. This is a hybrid role with 3 days a week on-site at our new Burnaby facility. What We Offer Competitive 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 venture Flexible working hours and hybrid arrangements Extended health benefits Professional development funding A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world Key Responsibilities: Own & Scale the Quality Management System (QMS) Maintain and continuously improve an ISO 13485 / MDSAP-compliant QMS Apply a pragmatic approach: ensuring compliance without unnecessary complexity Ensure audit readiness across: Document control Training systems and records Equipment and process controls Supplier quality CAPA and complaint handling Identify system gaps and implement scalable, practical solutions Conduct CAPA trend analysis and report insights to leadership Ensure all quality records are accurate, complete, and audit-ready Facility Transition Ensure QMS compliance throughout the facility relocation to Burnaby Update documentation, risk assessments, and processes tied to the new site Partner cross-functionally with Operations to minimize disruption Support validation and readiness of the new facility Audit & Compliance Leadership Lead preparation for the ISO 13485 surveillance audit Act as the primary QA contact during internal and external audits Strengthen audit readiness (e.g., training documentation, system gaps, UDI compliance) Set and track annual quality objectives with senior leadership Present KPIs, trends, and quality insights across the organization Product & Design Quality Support Design Controls (requirements, risk management) Develop and implement test strategies and validation plans Partner with Engineering to balance speed, compliance, and practicality Lead Quality Reviews with Operations and Engineering to drive continuous improvement Supplier & Manufacturing Quality Partner with Supply Chain on supplier qualification, monitoring, and performance Ensure quality consistency across sterile kits and components Lead CAPAs and complaint investigations: Root cause analysis Corrective actions Timely closure Support new supplier approvals (including regulatory requirements) Requirements 5–10+ years in Quality Assurance within medical devices or manufacturing environment (ISO 13485 environment or equivalent) Strong working knowledge of: ISO 13485 or equivalent FDA 21/CFR 820 Proven experience with: Audits (internal & external) CAPA systems Supplier quality QMS ownership Background in a technical field (engineering, science, or equivalent) Strong communication skills (including customer-facing quality discussions) Ability to operate in a fast-paced, scaling environment Nice-to-Have Experience with MDSAP and/or FDA regulatory requirements Background with Class I/II devices, sterile products, or orthopaedics ISO 13485 or ISO 9001 Lead Auditor certification Experience supporting U.S. regulatory operations (e.g., UDI submissions) Experience supporting or leading facility changes, audits, or scaling environments Experience with internationally recognized standards for medical device development (e.g., ISO10993, ISO14971, IEC 60601, ISO 11135, ISO 11137) Desired Capabilities and Traits Hands-on operator: You execute while thinking strategically Pragmatic problem solver: You know what’s required vs. what’s unnecessary Detail-oriented: You ensure systems hold up under audit scrutiny Cross-functional partner: You build trust across Engineering, Ops, and Supply Chain Balanced mindset: You protect quality without slowing the business Why 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 Inclusion Arbutus 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. If this resonates with you, please apply – even if you don’t feel like you “check all the boxes.” Also, 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 streamlines 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 .