Junior Quality Engineer – Medical Devices

About the role

NovintiX is seeking a Junior Quality Engineer to support the development and maintenance of labeling for complex medical devices. You will work closely with product experts to ensure labels meet regulatory, safety, and business requirements for global markets.

Key responsibilities

• Investigate product, process, supplier and quality system non‑conformances.
• Conduct root‑cause analysis using 5 Whys, Fishbone Diagram and Fault Tree Analysis.
• Initiate, manage and track CAPA activities through closure and verify their effectiveness.
• Support internal, customer and regulatory audits related to NC and CAPA.
• Perform risk assessments, develop and maintain Risk Management Files (ISO 14971) and conduct FMEA, hazard analysis and other risk‑assessment activities.
• Collaborate with R&D, Manufacturing, Regulatory Affairs and Operations on risk mitigation and remediation.
• Assist quality activities during business transformations, acquisitions, site transfers and system migrations, including validation, verification and change‑control.

Required profile

• 2+ years of experience in quality engineering within the medical‑device or healthcare sector.
• Familiarity with ISO 13485, FDA regulations and ISO 14971 risk‑management standards.
• Proven ability to conduct root‑cause analysis, CAPA management and risk assessments.
• Experience working with cross‑functional teams and supporting audits.

Required skills

• Root‑cause analysis (5 Whys, Fishbone Diagram, Fault Tree Analysis)
• CAPA management
• ISO 13485 compliance
• FDA regulatory knowledge
• ISO 14971 risk‑management
• Failure Mode and Effects Analysis (FMEA)
• Hazard analysis and risk assessment
• Change‑control and validation activities

What we offer

• Opportunity to work on high‑impact medical‑device projects for global clients.
• Collaborative environment with multidisciplinary teams.
• Professional development in quality and regulatory domains.