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 position 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

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

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

Set and track annual quality objectives with senior leadership

Present KPIs, trends,



and quality insights across the organization

Product & Design Quality

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

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)

Robust working knowledge of:

ISO 13485 or equivalent

FDA 21/CFR 820

Proven experience with:

Audits (internal & external)

CAPA systems

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, andwhy 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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📌 Quality Assurance Lead (British Columbia)
🏢 Arbutus Medical
📍 British Columbia