Onsite Quality Assurance Engineer - Manufacturing & CAPA

Comrise; Portage (MI); Presencial; USD 60.000 - 90.000; Jornada completa

Descripción de la vacante

Comrise in Portage, MI is seeking a Quality Assurance Engineer. You will support QA, QC and preventive activities within a manufacturing environment, collaborating with Operations, Engineering, suppliers and stakeholders to identify issues and implement corrective and preventive actions.

The ideal candidate is analytical, detail-oriented, and able to work cross-functionally to ensure product quality, regulatory compliance, and continuous improvement across operations.

Formación

• Bachelor's degree in a related field.
• 0–2 years of quality assurance/quality engineering experience.
• Familiarity with ISO 13485, GDP, GMP.
• Foundational understanding of risk management, CAPA, audits, and statistics.
• Proficiency in MS Word, Excel, and PowerPoint.
• Excellent written and verbal English communication.

Responsabilidades

• Partner with Operations and cross-functional teams to maintain and improve product and process quality.
• Support regulatory compliance and internal quality procedures.
• Assist with internal and external audits.
• Own nonconformances and supplier-related NCs; drive timely resolution.
• Lead or support CAPAs with root cause analysis and corrective actions.
• Apply Lean principles and track KPIs for process improvements.
• Collaborate with suppliers to ensure quality materials and services.

Conocimientos

Analytical thinking

Attention to detail

Problem solving

Written and verbal communication

Cross-functional collaboration

Educación

Bachelor's degree

Descripción del empleo

Comrise in Portage, MI is seeking a Quality Assurance Engineer. You will support QA, QC and preventive activities within a manufacturing environment, collaborating with Operations, Engineering, suppliers and stakeholders to identify issues and implement corrective and preventive actions.

The ideal candidate is analytical, detail-oriented, and able to work cross-functionally to ensure product quality, regulatory compliance, and continuous improvement across operations.