Quality Engineer III – Medical Device

About the role

We are seeking a Quality Engineer III to join our medical‑device team, driving the integration of novel catheter‑based technologies. The role focuses on process characterization, validation, scale‑up and automation while ensuring the highest regulatory compliance.

Key responsibilities

• Design, execute and document validation protocols for new medical devices.
• Lead process characterization, scale‑up and automation activities.
• Identify and mitigate quality risks, championing proactive quality assurance.
• Conduct internal and external audits as a subject‑matter expert.
• Drive continuous improvement using Lean, Six Sigma and statistical methods.
• Mentor junior engineers and collaborate with suppliers, manufacturing and regulatory affairs.

Required profile

• Honours Bachelor’s degree (Level 8) or higher in a STEM discipline.
• Minimum 5 years of experience in the medical‑device or similarly regulated industry.
• Proven track record in validation and quality management system implementation.

Required skills

• Validation planning and execution.
• Quality Management Systems (ISO, MDD, MDR).
• Risk management and process documentation.
• Statistical analysis tools.
• Lean and Six Sigma methodologies.
• Process characterization, scale‑up and automation.

What we offer

• Market‑leading salary commensurate with experience.
• Comprehensive health and wellness benefits.
• Ongoing training and clear career progression.
• Opportunity to work on cutting‑edge technology impacting patients worldwide.