Hands-On QA/RA Leader — Medical Devices

Arbutus Medical Inc.; Burnaby; Hybrid; CAD 115,000 - 125,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work arrangements

Extended health benefits

Ground floor opportunity

Job summary

Arbutus Medical Inc. is seeking a hands-on Manager, Quality Assurance & Regulatory Affairs (QA/RA) to own the QA/RA function. As the first dedicated hire, you will roll up your sleeves to execute CAPAs, complaints, audits, QMS management, and regulatory activities while building the team for tomorrow.

You will lead the QA/RA function, establish KPIs, and develop scalable systems to protect patient safety and regulatory compliance as the company grows. Hybrid work arrangements are available.

Qualifications

• 5–10+ years in QA/RA leadership in medical devices or controlled manufacturing.
• ISO 13485 environment experience and ownership of QA/RA functions.
• Strong auditing, CAPA, QMS ownership, and regulatory database experience.
• Technical background in engineering or science and excellent communication.

Responsibilities

• Lead the QA/RA function and team, setting priorities and ensuring timely completion.
• Own and scale the QMS, maintaining ISO 13485 / MDSAP compliance and audit readiness.
• Oversee facility transition to Burnaby, update docs and risk assessments.
• Lead ISO 13485 surveillance audits and regulatory submissions as needed.
• Drive product and design quality through testing strategies and cross‑functional partnerships.

Skills

Quality Assurance Leadership

Regulatory Affairs

QMS Management

Audits & CAPA

Cross-functional Leadership

Job description

Arbutus Medical Inc. is seeking a hands-on Manager, Quality Assurance & Regulatory Affairs (QA/RA) to own the QA/RA function. As the first dedicated hire, you will roll up your sleeves to execute CAPAs, complaints, audits, QMS management, and regulatory activities while building the team for tomorrow.

You will lead the QA/RA function, establish KPIs, and develop scalable systems to protect patient safety and regulatory compliance as the company grows. Hybrid work arrangements are available.