Quality Engineer I — Medical Device Validation & CAPA

Cirtec Medical; Sturtevant (WI); On-site; USD 78,000 - 94,000; Full time

Job summary

Cirtec Medical, in Wisconsin, seeks a Quality Engineer to monitor and audit quality across manufactured goods in the medical device sector. You will identify root causes of defects, drive corrective actions, and interact with customers and suppliers to support engineering projects.

The role focuses on quality systems, CAPA management, and process validation in a non-remote environment. Strong data analysis and communication skills are essential.

Qualifications

• Bachelor's degree in engineering discipline.
• 1+ years of relevant work experience.
• Fluent in using computer systems for data analysis (MS Office).
• Read, write and speak fluent English.
• Excellent verbal communication, organizational and management skills.
• Training or equivalent experience in Word, Excel, PowerPoint, Access.
• Ability to implement quality programs and present data for continuous improvement.
• ISO 13485 background.
• Medical Device 21 CFR 820 knowledge.
• Extrusion/Molding and/or manufacturing experience.

Responsibilities

• Provide Quality Engineering support for engineering project development or sustained manufacturing.
• Provide Quality Project Management support for product transfers from development to validation.
• Validation System Owner for the validation master plan and determinations.
• Develop and maintain Validation SOPs.
• Develop and maintain project Quality Plans for assigned projects.
• Develop protocols, perform analyses, and write reports for validations and DOEs.
• Support IQ/OQ protocols to ensure QC compliance.
• Provide Quality Engineering support for manufacturing.
• CAPA system owner for corrective action procedures.

Skills

Verbal communication

English fluency

Data analysis

MS Office

Quality systems

21 CFR 820 knowledge

ISO 13485

Manufacturing experience

Education

Bachelor's degree in engineering

Tools

Microsoft Office

Job description

Cirtec Medical, in Wisconsin, seeks a Quality Engineer to monitor and audit quality across manufactured goods in the medical device sector. You will identify root causes of defects, drive corrective actions, and interact with customers and suppliers to support engineering projects.

The role focuses on quality systems, CAPA management, and process validation in a non-remote environment. Strong data analysis and communication skills are essential.