Senior QMS Quality Engineer - Medical Devices Leader

Vital Bio; Oakville; On-site; CAD 110,000 - 150,000; Full time

Job summary

Vital Bio in Oakville, Ontario seeks a Senior QMS Quality Engineer to lead the quality management system across the product lifecycle. You will partner with Quality, Regulatory Affairs, R&D, Manufacturing, and Supply Chain to ensure compliance with FDA QMSR, ISO 13485, and other applicable standards in a regulated medical device environment.

You will drive CAPA, change control, document control, training, audits, supplier quality, and continuous improvement initiatives, while supporting

Qualifications

• Lead QMS initiatives including CAPA, change control, document control, training, audits, supplier quality, and management review.
• Support product development, verification, validation, commercialization, and post-market activities within a regulated medical device environment.
• Diagnostics, point-of-care diagnostics, molecular diagnostics, or IVD experience strongly preferred.

Responsibilities

• Maintain and improve the QMS in line with regulatory requirements and industry standards.
• Configure and maintain workflows for document control, training, CAPA, nonconformance, change control, complaints, supplier quality, and audits.
• Support audits, inspections, and readiness activities across the organization.

Skills

QMS leadership

eQMS administration

CAPA management

Change control

Audits & inspections

Document control

Risk management

Regulatory compliance

Cross-functional collaboration

Tools

eQMS software

Job description

Vital Bio in Oakville, Ontario seeks a Senior QMS Quality Engineer to lead the quality management system across the product lifecycle. You will partner with Quality, Regulatory Affairs, R&D, Manufacturing, and Supply Chain to ensure compliance with FDA QMSR, ISO 13485, and other applicable standards in a regulated medical device environment.

You will drive CAPA, change control, document control, training, audits, supplier quality, and continuous improvement initiatives, while supporting