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 Audit Strengthening quality systems, audit readiness, and regulatory complianceAs 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 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 benefitsProfessional development fundingA purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the worldKey Responsibilities:Own & 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 control Training systems and recordsEquipment and process controlsSupplier qualityCAPA 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 auditsStrengthen audit readiness (e.g., training documentation, system gaps, UDI compliance)Set and track annual quality objectives with senior leadershipPresent KPIs, trends, and quality insights across the organizationProduct & Design QualitySupport Design Controls (requirements, risk management)Develop and implement test strategies and validation plansPartner with Engineering to balance speed, compliance, and practicalityLead Quality Reviews with Operations and Engineering to drive continuous improvementSupplier & Manufacturing QualityPartner 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)RequirementsRequirements5–10+ 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 systemsSupplier qualityQMS ownershipBackground in a technical field (engineering, science, or equivalent)Strong 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 businessBenefitsWhy 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. 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.
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
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
Benefits
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.
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BLANKSLATE Partners: a team of highly skilled and seasoned professionals providing top quality outsourced talent resource solutions.
What sets us apart from all the other consultants, outsourcers and people-solution-ists out there is that we’re turning traditional structure on it’s head; we operate rooted in partnership and learning - a change-up from traditional agencies. We’re a ‘get in there and get your hands dirty’ kind of team who sees the value in businesses finding success in their people - not who simply finds value in receiving a fee for our service. And, as we source, place, immigrate/relocate, train and support the retainment of your next all star employee(s), we’re going to do it with you - side by side, shoulder to shoulder.
http://blankslate.partners
