Onsite Manufacturing Quality Engineer (CAPA & CI)

ICU Medical; Dublin (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

ICU Medical is seeking a Manufacturing Quality Engineer to oversee manufacturing operations, ensure compliance with cGMP and ISO standards, and drive continuous improvement across quality systems. The role emphasizes cross-functional coaching, data analysis, and project management to resolve quality issues and deliver timely results at the Dublin, OH facility.

Ideal candidates have a Bachelor's in Engineering, 2–4 years in a regulated environment, and proficiency with PFMEAs/DFMEAs, Minitab, and

Qualifications

• Experience with cGMP requirements and quality systems in manufacturing.
• Proficiency with PFMEAs/DFMEAs, IQ/OQ/PQ, TMV, Gage R&R/MSA.
• Ability to perform root cause investigations using 5 Why/Ishikawa and data analysis.

Responsibilities

• Owns non-conforming reports and CAPAs from initiation to closure.
• Performs data analysis and tracking of NCRs to identify systemic improvements.
• Supports risk assessments and validation activities (IQ/OQ/PQ).
• Leads or participates in cross-functional improvement projects.
• Conducts safety inspections and ensures a safe work environment.

Skills

Quality oversight

cGMP knowledge

Problem solving

Cross-functional collaboration

Data analysis

Project management

Communication

Education

Bachelor's degree in Engineering or STEM

Tools

Minitab

Job description

ICU Medical is seeking a Manufacturing Quality Engineer to oversee manufacturing operations, ensure compliance with cGMP and ISO standards, and drive continuous improvement across quality systems. The role emphasizes cross-functional coaching, data analysis, and project management to resolve quality issues and deliver timely results at the Dublin, OH facility.

Ideal candidates have a Bachelor's in Engineering, 2–4 years in a regulated environment, and proficiency with PFMEAs/DFMEAs, Minitab, and