Quality & Regulatory Lead – Medical Devices (Contract)

s r t med staff; Toronto; On-site; CAD 61,000 - 82,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Medical benefits

Pension plan

Paid vacation

Parental leave

Education assistance

Onsite & hybrid work

Volunteer programs

Training resources

Job summary

Olympus is seeking a Quality Assurance/Regulatory Affairs professional at our Ontario site near Vaughan for a 13–14 month contract. The role maintains and improves the site Quality Management System to ensure ISO 13485, Health Canada regulations, and company policies are met.

As the site SME for CAPA, NCR, Audits, Change Control, Document Control, Training and Management Review, you will partner with cross‑functional teams to drive compliance, inspection readiness, risk reduction and continuous

Qualifications

• Bachelor’s degree in a technical field is required.
• Minimum of 3 years of experience in medical devices or a regulated industry.
• Experience with CAPA, NCR, Audit, Change Control, Document Control, and Training is required.
• Knowledge of ISO 13485, FDA QMSR/QSR and Health Canada regulations, risk management, and root cause analysis is essential.
• Occasional outside-hours support for audits, inspections, and global projects may be required.

Responsibilities

• Support global quality initiatives and harmonization activities.
• Analyze quality metrics, identify trends, and prepare Management Review reports.
• Develop, maintain, and improve QMS processes and work instructions.
• Support investigations and risk assessments within NCR/CAPA/DEV programs.
• Administer CAPA, NCR, Audit, Change Control, Training, and Document Control programs.
• Ensure CAPA/NCR/Audit execution is governed and closed with objective evidence.
• Support regulatory inspections and customer/internal audits and readiness.
• Drive continuous improvement projects to enhance compliance and process effectiveness.
• Perform special assignments as directed.

Skills

CAPA

NCR

Audit

Change Control

Document Control

Training

Regulatory knowledge

Root cause analysis

Data analysis

Microsoft 365

Education

Bachelor’s degree in Engineering, Science, Quality, Life Sciences, or related technical discipline

Tools

Microsoft 365

Job description

Olympus is seeking a Quality Assurance/Regulatory Affairs professional at our Ontario site near Vaughan for a 13–14 month contract. The role maintains and improves the site Quality Management System to ensure ISO 13485, Health Canada regulations, and company policies are met.

As the site SME for CAPA, NCR, Audits, Change Control, Document Control, Training and Management Review, you will partner with cross‑functional teams to drive compliance, inspection readiness, risk reduction and continuous