Quality Engineer – Medical Devices (On-Site in Danbury)

AB Electronics; Danbury (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

AB Electronics is seeking a proactive Quality Engineer to join our team in Danbury, CT. You will ensure products meet the highest quality standards and regulatory requirements, collaborating with cross-functional teams to implement QA processes and maintain the QMS.

The role emphasizes continuous improvement and compliance with FDA regulations and ISO 13485/ISO 9001. You will run audits, qualify equipment, train staff, and prepare regulatory documentation, driving quality initiatives across the

Qualifications

• Bachelor's degree in a related engineering field.
• 3–5 years in quality engineering or QA in manufacturing.
• Experience conducting quality audits and corrective actions.
• Ability to read CAD data, blueprints, and quality agreements.
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills.

Responsibilities

• Develop, implement, and maintain quality assurance protocols and procedures.
• Conduct quality audits to ensure compliance and identify improvements.
• Conduct machine qualifications to ensure equipment meets performance standards.
• Collaborate with project management and production teams to integrate QA practices.
• Facilitate training sessions on quality systems.
• Prepare documentation for regulatory submissions and maintain records.
• Lead root cause and corrective action using 5-Why, Fishbone, and 8-D methods.

Skills

Quality engineering

Quality audits

Root cause analysis

Documentation

Regulatory compliance

Project management

Analytical skills

Communication skills

Education

Bachelor's degree in quality, industrial, or mechanical engineering

Tools

IQ/OQ/PQ

AS9100

FMEA

PCP

ISO 13485

Job description

AB Electronics is seeking a proactive Quality Engineer to join our team in Danbury, CT. You will ensure products meet the highest quality standards and regulatory requirements, collaborating with cross-functional teams to implement QA processes and maintain the QMS.

The role emphasizes continuous improvement and compliance with FDA regulations and ISO 13485/ISO 9001. You will run audits, qualify equipment, train staff, and prepare regulatory documentation, driving quality initiatives across the