Quality Engineer I – Medical Devices

About the role

Cirtec Medical is seeking a Quality Engineer I to support the development and sustained manufacturing of Class II and III medical devices. The role focuses on monitoring product quality, investigating root causes of defects, and implementing corrective solutions while collaborating with customers, suppliers, and internal teams.

Key responsibilities

• Provide quality engineering support for engineering projects and ongoing manufacturing.
• Develop and manage the Validation Master Plan and related SOPs.
• Create validation protocols, perform statistical analyses, and conduct Design of Experiments (DOE).
• Support Installation Qualification (IQ) and Operational Qualification (OQ) activities.
• Own the CAPA system, resolve CAPA and complaint investigations, and manage material disposition via NCRs.
• Assist with product transfers from development to validation and from validation to production.
• Approve vendors, monitor performance data (SCAR, on‑time delivery), and assess supplier capabilities.
• Document procedural changes to maintain compliance with the quality system.
• Develop and maintain quality systems, audit support for internal, customer, and third‑party audits.
• Drive continuous improvement initiatives and create production quality control plans.
• Implement and maintain Statistical Process Control (SPC) for production processes.
• Support Failure Modes & Effects Criticality Analysis (FMECA) and additional DOE activities.

Required profile

• Experience in quality engineering within medical device manufacturing.
• Ability to analyze defects, determine root causes, and develop corrective actions.
• Strong collaboration skills for interacting with customers, suppliers, and cross‑functional teams.

Required skills

• Validation Master Plan development
• Standard Operating Procedures (SOPs) creation
• Statistical analysis
• Design of Experiments (DOE)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Corrective and Preventive Action (CAPA) management
• Non‑Conformance Report (NCR) handling
• Statistical Process Control (SPC)
• Failure Modes & Effects Criticality Analysis (FMECA)
• Vendor approval and performance monitoring
• Supplier Corrective Action Request (SCAR) processing
• Audit support
• Continuous improvement initiatives
• Production quality control planning