Quality Engineer, Medical Devices & GMP

Comar; Buena (NJ); On-site; USD 69,000 - 85,000; Full time

Benefits offered by this job

Medical benefits

Dental insurance

401(k) plan

Job summary

Comar is seeking a Quality Engineer at our Buena, NJ plant to advance product quality, support new product introductions, and drive continuous improvement across manufacturing processes. You will work within a cross-functional team to ensure compliant practices and robust quality systems.

The role emphasizes practicing cGMP/ISO standards, leading CAPA and deviation handling, and mentoring plant staff toward quality excellence and sustained process improvements.

Qualifications

• Bachelor's degree or higher in technology, engineering, science, or related field.
• Experience in manufacturing quality environments and quality systems.
• Strong writing, data analysis, and procedural documentation skills.

Responsibilities

• Improve operational quality and support pilot programs.
• Lead CAPA investigations and corrective actions with cross-functional teams.
• Ensure compliance with FDA cGMP, ISO 13485/9001 standards and internal SOPs.
• Develop and maintain QMS documents, work instructions, SOPs and forms.
• Perform training and competency assessments of plant personnel.

Skills

Quality engineering

Regulatory compliance

CAPA investigations

GMP/ISO knowledge

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

QMS documentation

Job description

Comar is seeking a Quality Engineer at our Buena, NJ plant to advance product quality, support new product introductions, and drive continuous improvement across manufacturing processes. You will work within a cross-functional team to ensure compliant practices and robust quality systems.

The role emphasizes practicing cGMP/ISO standards, leading CAPA and deviation handling, and mentoring plant staff toward quality excellence and sustained process improvements.