Quality Engineer I

About the role

Cirtec Medical is seeking a Quality Engineer I to monitor and audit the quality of manufactured medical devices. The role focuses on identifying defects, determining root causes, and developing corrective solutions while supporting engineering projects and interacting with customers and suppliers.

Key responsibilities

• Provide quality engineering support for engineering projects and sustained manufacturing.
• Manage validation activities, including development of the validation master plan, SOPs, and project quality plans.
• Develop protocols, perform statistical analyses, and write validation reports, including DOE studies.
• Support IQ (Installation Qualification) and OQ (Operational Qualification) implementation.
• Own the CAPA system, resolve corrective actions, and handle complaint investigations.
• Manage material disposition through NCRs and support product transfers from validation to production.
• Approve vendors, assess performance data, and maintain vendor records.
• Document procedure changes, develop quality systems, and support internal, customer, and third‑party audits.
• Drive continuous improvement, maintain SPC charts, and contribute to FMECA and DOE activities.

Required profile

• Experience in quality engineering within the medical device industry.
• Ability to interact effectively with customers, suppliers, and cross‑functional teams.
• Strong analytical mindset for root‑cause analysis and problem solving.

Required skills

• Statistical Process Control (SPC)
• Failure Modes & Effects Criticality Analysis (FMECA)
• Design of Experiments (DOE)
• CAPA management
• Validation planning and execution
• Audit support (internal, customer, third‑party)
• Vendor approval and performance assessment