Quality Assurance Lead - Arbutus Medical Systems

BLANKSLATE Partners • Burnaby, BC

5d • Hybrid

About The Position

Arbutus Medical is seeking a hands-on Quality Assurance Lead to own and scale their Quality Management System (QMS) while supporting a critical period of operational growth. This role will play a key leadership role in relocating the facility, preparing for an ISO 13485 Surveillance Audit, and 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 systems for growth. This is a hybrid role with 3 days a week on-site at their new Burnaby facility.

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 Haves

• 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)

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
• 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
• 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
• 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
• 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)

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed