Quality Systems Specialist — ISO 13485 & CAPA Expert (Hybrid)

Olympus Corporation; Richmond Hill; Hybrid; CAD 61,000 - 82,000; Full time

Job summary

Olympus Corporation in Ontario, Richmond Hill, is seeking a contract Quality & Regulatory Affairs professional to maintain and continuously improve the site Quality Management System (QMS) to ensure compliance with ISO 13485, Health Canada regulations, and global quality standards, enabling safe, effective patient care.

You will serve as the site subject matter expert for quality processes including CAPA, NCR, audits, change control, document control and training.

Qualifications

• Bachelor’s degree in engineering, science, quality, life sciences, or related field.
• Minimum of 3 years in medical devices or a regulated industry.
• Experience with CAPA, NCR, audits, change control, and training 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, procedures, and work instructions.
• Support investigations, root cause analysis, 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 monitored to drive patient centric risk decisions demonstrated in objective evidence and timely closure.
• Support regulatory inspections, customer audits, internal audits and inspection readiness activities.
• Drive continuous improvement projects to improve compliance and process effectiveness.
• Perform special assignments as directed.

Skills

CAPA & NCR processes

Audit & inspection readiness

Risk assessment & root cause analysis

Regulatory compliance understanding

Documentation control

Education

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

Tools

CAPA system

NCR process

Audit management

Change Control

Document Control

Training management

Microsoft 365

Job description

Olympus Corporation in Ontario, Richmond Hill, is seeking a contract Quality & Regulatory Affairs professional to maintain and continuously improve the site Quality Management System (QMS) to ensure compliance with ISO 13485, Health Canada regulations, and global quality standards, enabling safe, effective patient care.

You will serve as the site subject matter expert for quality processes including CAPA, NCR, audits, change control, document control and training.