Quality Engineer

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

Quality Engineer

Danbury, CT | Full-Time | On-Site (7:00am - 3:30pm)

About the Role

AB Electronics is looking for a proactive and detail-oriented Quality Engineer to join our team. The ideal candidate will be capable of ensuring that our products meet the highest quality standards and comply with relevant regulations. This role involves collaborating with cross-functional teams to implement quality assurance processes, conduct audits, and maintain quality management systems. The Quality Engineer will play a critical role in driving continuous improvement initiatives and ensuring compliance with FDA regulations and ISO 13485 and ISO 9001 standards.

What You'll Do

• Develop, implement, and maintain quality assurance protocols and procedures.
• Conduct quality audits to ensure compliance with internal and external standards, and to identify trends and areas for improvement.
• Conduct machine qualifications to ensure equipment meets overall performance standards.
• Collaborate with project management and production teams to integrate quality assurance practices throughout the product lifecycle.
• Facilitate training sessions on quality systems and best practices for staff.
• Prepare documentation for regulatory submissions and maintain records in accordance with FDA regulations.
• Lead root cause and corrective action, using 5-Why, Fishbone, and 8-D activities.

What You Bring

• Bachelor's degree in quality, industrial, or mechanical engineering, or a related field.
• 3-5 years of experience in quality engineering, quality assurance, or a similar role in a manufacturing environment (electronics contract manufacturing preferred).
• Strong understanding of project management principles related to quality engineering.
• Experience conducting quality audits and implementing corrective actions.
• Experience leading and interpreting customer documents, including CAD data, blueprints, and quality agreements.
• Excellent analytical skills, with strong attention to detail and problem-solving capabilities.
• Robust written and verbal communication skills.

What Will Set You Apart

• Experience in electronics manufacturing preferred.
• Experience with ISO 13485, ISO 9001, and AS9100 standards is highly desirable.
• Experience with IQ/OQ/PQ, AS9102 FAIR, FMEA, and PCP is a plus.
• Familiarity with FDA regulations governing medical devices or related industries.
• Knowledge of quality management systems and their applications in manufacturing environments.
• Familiarity with lean principles.

Physical Requirements

Must have strong visual acuity for inspecting small components, including under magnification using a microscope. Able to perform repetitive hand and arm movements with fine dexterity. A able to sit or stand for extended periods and lift up to 25 lbs occasionally. Comfortable wearing PPE and working in a production environment.

Why AB Electronics?

We're a quality-driven electronics manufacturer where people, processes, and technology come together. You'll be part of a supportive team environment with real opportunities to grow.

AB Electronics is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Note: Pay range presented for informational purposes and subject to change. Pay rate determinations based on experience, skill level, and business needs.