Quality Engineer II – Medical Device Manufacturing

About the role

Cirtec Medical is seeking a Quality Engineer II to oversee and audit the quality of medical‑device products throughout development and production. You will identify defects, determine root causes, and implement corrective solutions while collaborating with customers and suppliers on engineering projects.

Key responsibilities

• Provide quality engineering support for product development and sustained manufacturing.
• Manage validation activities, including the validation master plan, SOPs, protocols, statistical analysis, and reporting.
• Support IQ (Installation Qualification) and OQ (Operational Qualification) to ensure system compliance.
• Maintain and execute CAPA processes, resolve investigations, and handle material disposition via NCRs.
• Evaluate vendors, review performance data, and manage SCARs.
• Develop and maintain quality plans, production quality control plans, and SPC charts.
• Assist with internal, customer, and third‑party audits and drive continuous‑improvement initiatives.
• Facilitate FMECA and DOE activities for critical process analysis.

Required profile

• Strong analytical mindset with the ability to detect defects, perform root‑cause analysis, and devise solutions.
• Experience interacting with customers and suppliers to support engineering projects.
• Commitment to growth, innovation, and collaborative problem‑solving.

Required skills

• Validation planning and execution
• Statistical analysis and Design of Experiments (DOE)
• Statistical Process Control (SPC)
• Failure Mode, Effects, and Criticality Analysis (FMECA)
• CAPA management
• IQ/OQ qualification
• Non‑Conformance Report (NCR) handling
• Supplier Corrective Action Request (SCAR) processing