Quality Engineer I – Medical Device Manufacturing

About the role

Cirtec Medical is seeking a Quality Engineer I to support the monitoring and auditing of product quality across its medical device manufacturing operations. The role focuses on identifying defects, determining root causes, and implementing corrective solutions while collaborating with customers and suppliers.

Key responsibilities

• Provide quality engineering support for engineering projects and sustained manufacturing.
• Own the validation system, develop the validation master plan, and maintain validation SOPs.
• Create and manage project quality plans, protocols, statistical analyses, and validation reports, including DOE studies.
• Develop and execute IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
• Serve as CAPA system owner, handling corrective actions, complaint investigations, and material disposition via NCRs.
• Approve vendors, assess performance data (SCAR, on‑time delivery), and document procedural changes.
• Support internal, customer, and third‑party audits and drive continuous improvement initiatives.
• Establish and maintain SPC charts, FMECA, and other quality tools for production processes.

Required profile

• Experience in quality engineering within a regulated medical‑device environment.
• Ability to monitor manufacturing quality, conduct root‑cause analysis, and develop corrective solutions.
• Strong collaboration skills for interfacing with customers, suppliers, and cross‑functional teams.

Required skills

• Validation master planning and SOP development
• CAPA management and NCR handling
• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Failure Modes & Effects Criticality Analysis (FMECA)
• IQ/OQ protocol creation
• Vendor performance assessment (SCAR)