Quality Engineer III: Medical Devices, Day One Benefits

JVT Advisors; Bethel (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

JVT Advisors in Bethel, CT is seeking a Quality Engineer III to apply advanced quality engineering methods to daily tasks and to lead risk management across product development and manufacturing processes. The role focuses on regulatory compliance with ISO 13485 and FDA 21 CFR 820, mentor colleagues, and drive continuous improvement while collaborating with customers and suppliers to resolve issues.

The position is full-time, on-site in Bethel, offering day-one benefits and opportunities to

Qualifications

• Must create job-related quality documentation.
• Familiar with ISO 13485 and FDA 21 CFR 820.
• Min 2 years in quality engineering for medical devices or equivalent.
• Strong technical writing and communication skills.
• Experience with statistical software (Minitab) or similar.
• Bachelor’s degree or equivalent experience.
• Interact with customers and suppliers; audits may be required.

Responsibilities

• Apply advanced quality engineering methods to tasks and projects.
• Lead risk management tools and practices.
• Conduct root cause investigations and verify corrective actions.
• Develop test methods for equipment, processes, and products.
• Maintain quality control plans aligned with risk levels.
• Implement statistical process controls and sampling plans.
• Ensure ISO 13485 and FDA 21 CFR 820 compliance.
• Lead QE on product development and continuous improvement.
• Mentor others in quality capabilities.
• Collaborate with customer quality personnel to resolve issues.
• Assist with troubleshooting production processes.
• Provide support for validation protocols.

Skills

Technical writing

Statistical analysis

Documentation

Education

Bachelor’s degree or equivalent experience

Tools

Minitab

Job description

JVT Advisors in Bethel, CT is seeking a Quality Engineer III to apply advanced quality engineering methods to daily tasks and to lead risk management across product development and manufacturing processes. The role focuses on regulatory compliance with ISO 13485 and FDA 21 CFR 820, mentor colleagues, and drive continuous improvement while collaborating with customers and suppliers to resolve issues.

The position is full-time, on-site in Bethel, offering day-one benefits and opportunities to