Senior Quality Engineer – Medical Device Labeling & Risk Management

About the role

NovintiX is seeking a Senior Quality Engineer to develop and maintain labels for complex medical devices. You will work closely with product experts to gather and standardise labelling content, ensuring compliance with global medical‑device regulations and business requirements.

Key responsibilities

• Facilitate root‑cause analysis using 5 Why, Fishbone, Fault Tree and Pareto techniques.
• Manage the full CAPA lifecycle and ensure regulatory compliance of CAPAs.
• Support internal, external, customer and regulatory audits related to CAPA activities.
• Conduct risk assessments (FMEA, ISO 14971, risk‑hazard, risk‑benefit analyses) throughout the product lifecycle.
• Evaluate quality events, complaints, deviations and audit findings for risk impact.
• Drive risk remediation programmes and verify effectiveness of controls.
• Collaborate with R&D, Manufacturing, Regulatory Affairs and Clinical teams to implement and monitor controls.
• Maintain risk management files, registers and documentation for system migrations.
• Coordinate change‑control activities and ensure data integrity during migrations.

Required profile

• Senior‑level experience in quality engineering for medical devices.
• Strong knowledge of ISO 14971 and other medical‑device regulatory standards.
• Proven ability to lead CAPA processes and risk‑management activities.
• Experience supporting audits and managing cross‑functional quality projects.

Required skills

• Root‑cause analysis methods (5 Why, Fishbone, Fault Tree, Pareto).
• CAPA lifecycle management.
• Risk assessment techniques (FMEA, ISO 14971, risk‑hazard, risk‑benefit analysis).
• Regulatory compliance and audit support.
• Labeling software for medical‑device label creation.

What we offer

• Competitive salary package.
• Health insurance coverage.
• Career growth opportunities.
• Employee recognition and rewards.
• Friendly and collaborative work culture.