Quality Engineer: FDA/ISO Compliance & QA Lead

Cs Llc; Miry Brook (CT); On-site; USD 75,000 - 105,000; Full time

Job summary

AB Electronics in Danbury, CT is seeking a proactive Quality Engineer to ensure products meet the highest quality standards and comply with FDA regulations, ISO 13485, and ISO 9001.

You will develop, implement, and maintain QA protocols, conduct audits, run machine qualifications, and drive continuous improvement across the product lifecycle, collaborating with manufacturing, engineering, and regulatory teams on on-site operations.

Qualifications

• Bachelor's degree in quality, industrial, or mechanical engineering or related field.
• 3–5 years in quality engineering/QA in manufacturing (electronics preferred).
• Experience with FDA/ISO13485/9001 regulatory environments.

Responsibilities

• Develop, implement, and maintain QA protocols and procedures.
• Conduct quality audits to ensure compliance and identify improvement opportunities.
• Perform machine qualifications to verify equipment meets performance standards.
• Collaborate with PM and production to integrate QA across product lifecycle.
• Facilitate training on quality systems for staff.
• Prepare documentation for regulatory submissions; maintain records per FDA rules.
• Lead root cause analysis and 8D/CAPA activities.

Skills

QA protocols

Audits

CAPA

Documentation

Regulatory knowledge

Education

Bachelor's degree in quality/industrial/mechanical engineering

Tools

QMS software

CAPA tools

Document control system

Job description

AB Electronics in Danbury, CT is seeking a proactive Quality Engineer to ensure products meet the highest quality standards and comply with FDA regulations, ISO 13485, and ISO 9001.

You will develop, implement, and maintain QA protocols, conduct audits, run machine qualifications, and drive continuous improvement across the product lifecycle, collaborating with manufacturing, engineering, and regulatory teams on on-site operations.