Quality Assurance Administrator supporting franchise quality assurance across 340 locations in North America. Ensuring compliance with insurance carrier standards and managing claims effectively.
About the role
- Quality Assurance Lead overseeing ISO compliance and QMS scaling for Arbutus Medical Systems. Guiding facility transition, audit preparation, and product quality strategy in a hybrid work environment.
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)
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
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