Quality Design & Development Engineer - Medical Devices

TOMZ Corporation; Berlin (CT); On-site; USD 85,000 - 110,000; Full time

Job summary

TOMZ Corporation in Berlin, CT is seeking an Application Engineer to join our Quality Engineering team. You will drive quality plans, risk management, and validation strategies across PDP activities and sustaining manufacturing.

The role requires collaboration with R&D, Manufacturing, and QA to ensure GDP/GMP compliance and successful audits. Ideal candidates have 2–5 years in a regulated manufacturing environment and hold a 4-year degree.

Qualifications

• Advanced education or certification coursework relevant to quality.
• Knowledge of statistical techniques to analyze process capability.
• Quality certification(s) such as ASQ CQE or equivalent.
• Experience with First Article Inspections and component qualifications.
• Familiarity with ISO 9001/13485, 21 CFR 820, EU MDR in product development.
• Experience supporting audits by customers and external regulatory agencies.
• Proficiency with Microsoft Office.

Responsibilities

• Develop and execute Quality Plans for design and development projects.
• Collaborate with engineering teams to support risk management documentation.
• Establish risk-based validation plan strategies with V&V rationales.
• Support qualification activities for customer processes and supplier design.
• Drive test method development and validation execution.
• Implement inspection plans for incoming, in-process, and final product.
• Represent Quality Engineering in design reviews and audits.
• Adhere to the TOMZ Quality Management System.

Skills

English communication

Problem solving

Team collaboration

Education

4-year degree

Tools

Microsoft Office

Job description

TOMZ Corporation in Berlin, CT is seeking an Application Engineer to join our Quality Engineering team. You will drive quality plans, risk management, and validation strategies across PDP activities and sustaining manufacturing.

The role requires collaboration with R&D, Manufacturing, and QA to ensure GDP/GMP compliance and successful audits. Ideal candidates have 2–5 years in a regulated manufacturing environment and hold a 4-year degree.