Quality Engineer I – Medical Device Industry

About the role

Cirtec Medical is seeking a Quality Engineer I to support the monitoring, auditing, and continuous improvement of manufactured medical devices. 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 product development and sustained manufacturing.
• Own validation activities, including creation of the validation master plan, SOPs, and execution of IQ/OQ protocols.
• Develop and maintain project quality plans, perform statistical analyses, and write validation reports.
• Manage CAPA processes, resolve complaints, and support material disposition via NCRs.
• Approve vendors, assess performance, and maintain SCAR records.
• Conduct internal, customer, and third‑party audits and support continuous‑improvement initiatives.
• Establish and maintain SPC charts and production quality control plans.
• Participate in FMECA and DOE studies to enhance process robustness.

Required profile

• Strong analytical mindset with a focus on root‑cause analysis.
• Experience working in a regulated medical‑device environment.
• Ability to interact effectively with cross‑functional teams, customers, and suppliers.
• Detail‑oriented and committed to compliance with quality systems.

Required skills

• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Failure Modes & Effects Criticality Analysis (FMECA)
• CAPA and NCR management
• IQ/OQ protocol development
• Validation master‑plan creation and SOP maintenance
• Statistical analysis and reporting