Quality Assurance Lead - Arbutus Medical Systems Job Burnaby area,BC Canada,Quality Assurance

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,, 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 (, 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 regulatory operations (, UDI submissions)

Experience supporting or leading facility changes, audits, or scaling environments

Experience with internationally recognized standards for medical device development (, ISO
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