Quality Engineer II

About the role

Cirtec Medical is seeking a Quality Engineer II to supervise and audit product quality across its medical device manufacturing operations. The role focuses on defect detection, root‑cause analysis, and development of corrective solutions while supporting engineering projects and supplier interactions.

Key responsibilities

• Provide quality engineering support for product development and sustained manufacturing.
• Manage validation activities, including development of the validation master plan, SOPs, protocols, statistical analysis, and reporting.
• Support IQ (facility qualification) and OQ (operational qualification) implementation to ensure compliance.
• Maintain and execute CAPA investigations, coordinate with customers and suppliers, and manage material disposition through NCRs.
• Oversee vendor approval, evaluate performance data, and handle SCAR tracking.
• Develop and maintain quality plans, SPC charts, and production quality control plans.
• Participate in internal, customer, and third‑party audits and drive continuous‑improvement initiatives.

Required profile

• Experience in quality engineering within the medical device industry.
• Familiarity with validation, CAPA, NCR, and vendor management processes.
• Ability to interact effectively with customers, suppliers, and cross‑functional teams.
• Strong analytical mindset for root‑cause analysis and statistical evaluation.

Required skills

• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Failure Mode and Effects Critical Analysis (FMECA)
• Validation master planning and protocol development
• CAPA and NCR management
• IQ/OQ qualification procedures

What we offer

• Opportunity to work on complex Class II and III medical devices.
• Collaborative environment focused on growth and innovation.
• Exposure to a broad portfolio including neuromodulation, cardiac rhythm management, and minimally invasive surgical systems.