Quality Engineer I – Medical Device Manufacturing

About the role

We are seeking a Quality Engineer I to join Cirtec Medical’s manufacturing team. The role focuses on monitoring and auditing the quality of medical‑device products, identifying root causes of defects, and implementing corrective solutions.

Key responsibilities

• Provide quality engineering support for engineering projects and sustained manufacturing.
• Own the validation system, develop and manage the validation master plan and related SOPs.
• Create and maintain project quality plans, protocols, statistical analyses, and validation reports, including DOE studies.
• Develop and execute IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
• Manage the CAPA system, resolve corrective actions, and handle complaint investigations.
• Support material disposition through NCRs and oversee vendor approval and performance assessment.
• Review and document procedural changes to ensure compliance with the quality system.
• Assist with internal, customer, and third‑party audits.
• Drive continuous improvement initiatives, maintain SPC charts, and conduct FMECA and DOE activities.

Required profile

Required skills

• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Failure Modes & Effects Criticality Analysis (FMECA)
• Validation (IQ/OQ) development and execution
• CAPA management
• NCR material disposition
• Vendor performance assessment