Quality Engineer – Medical Devices (ISO 13485/FDA)

Cs Llc; Danbury (CT); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Life Insurance

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Paid Holidays

Tuition Reimbursement

Job summary

AB Electronics in Danbury, CT is seeking a proactive Quality Engineer to ensure products meet quality standards and regulatory requirements. The role collaborates across teams to implement QA processes and maintain QMS, including FDA regulations and ISO 13485/9001.

Responsibilities include audits, machine qualification, training, and documentation for regulatory submissions, with a focus on continuous improvement and strong communication across functions.

Qualifications

• Bachelor's degree in quality, industrial, or mechanical engineering.
• 3–5 years of experience in quality engineering in manufacturing.
• Experience conducting quality audits and implementing corrective actions.

Responsibilities

• Develop, implement, and maintain quality assurance protocols and procedures.
• Conduct quality audits to ensure compliance and identify trends for improvement.
• 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 for staff.
• Prepare documentation for regulatory submissions and maintain records under FDA regulations.
• Lead root cause and corrective action using 5-Why, Fishbone, and 8-D.

Skills

Quality engineering

Audits

Regulatory awareness

Data analysis

Communication

Education

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

Job description

AB Electronics in Danbury, CT is seeking a proactive Quality Engineer to ensure products meet quality standards and regulatory requirements. The role collaborates across teams to implement QA processes and maintain QMS, including FDA regulations and ISO 13485/9001.

Responsibilities include audits, machine qualification, training, and documentation for regulatory submissions, with a focus on continuous improvement and strong communication across functions.