Quality Lead: GMP/ISO Compliance & Process Improvement

Comar; Buena (NJ); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Paid overtime

Health

Dental

Vision

Paid time off

401k with match

Job summary

Comar seeks a Quality Technician/Inspector in Buena, NJ to perform inspection, testing, and document control. You will review COAs, maintain batch records, and conduct GMP and line audits to ensure product quality.

The role requires 6+ years of QC experience with a high school/Vo-Tech background or 4+ years with an associate degree, plus proficiency in SPC, Gauge R&R, and ISO 13485 knowledge. Training and leading QC staff are key responsibilities.

Qualifications

• Experience in ISO certified or regulated environments.
• Proficiency with SPC and Gauge R&R methods.
• Ability to write routine reports and understand product drawings.
• Experience onboarding and training Quality Technicians I-III.

Responsibilities

• Perform Quality Technician and Inspector duties including inspection/testing and data collection.
• Review batch records and COAs, and perform investigations with root-cause analysis.
• Maintain controlled documents, SOPs, training records, and IQMS document control.
• Lead quality audits, GMP compliance, and ISO 13485 alignment.
• Develop and onboard Quality Technicians I-III and train staff on QA processes.

Skills

Quality control

SPC

Gauge R&R

Documentation

Leadership

Education

High school or Vo-Tech + 6+ years QC experience

Associate degree in science + 4+ years QC experience

Bachelor’s degree in science/engineering or equivalent

Tools

IQMS system

SPC tools

Calibration equipment

ISO 9001 knowledge

ISO 13485 knowledge

Job description

Comar seeks a Quality Technician/Inspector in Buena, NJ to perform inspection, testing, and document control. You will review COAs, maintain batch records, and conduct GMP and line audits to ensure product quality.

The role requires 6+ years of QC experience with a high school/Vo-Tech background or 4+ years with an associate degree, plus proficiency in SPC, Gauge R&R, and ISO 13485 knowledge. Training and leading QC staff are key responsibilities.