Quality Application Engineer: Design Controls & Validation

TOMZ Corporation; Berlin (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

TOMZ Corporation in Berlin, CT is seeking a Quality Engineer to guide design & development with a focus on quality design controls and process validation.

You will collaborate with R&D and manufacturing to implement robust quality plans, risk assessments, and supplier qualifications while ensuring compliance with ISO 9001, ISO 13485, and 21 CFR 820.

Experience with audits by customers and regulators, plus strong English communication and proficiency in MS Office, are essential.

Qualifications

• Minimum 4-year degree or equivalent in engineering or quality discipline.
• 2–5 years’ experience in a regulated manufacturing environment.
• Medical device manufacturing experience in regulated environments (Class I–III).
• Knowledge of ISO 9001/13485, 21 CFR 820, EU MDR.
• ASQ CQE or equivalent quality certification is preferred.
• Strong verbal and written English communication.
• Proficiency with Microsoft Office.
• Self-starter with ability to collaborate across R&D, Manufacturing, and QA.

Responsibilities

• Develop and execute Quality Plans for Design & Development projects.
• Collaborate with engineering to update Risk Management documentation.
• Establish severity and risk-based validation strategies with V&V rationales.
• Support qualifications for customer manufacturing processes and supplier audits.
• Drive Test Method development and validations.
• Implement inspection plans for Incoming, In-Process and Final Product.
• Represent Quality Engineering in design reviews.
• Support audits by customers and regulatory agencies.
• Apply systematic problem-solving to quality issues and nonconformances.
• Ensure site Quality Management System compliance.

Skills

Statistical techniques

Quality certifications

First Article Inspections

Auditing

English communication

Cross-functional collaboration

Microsoft Office

Independent work

Education

Bachelors degree or higher in Engineering/Quality

Job description

TOMZ Corporation in Berlin, CT is seeking a Quality Engineer to guide design & development with a focus on quality design controls and process validation.

You will collaborate with R&D and manufacturing to implement robust quality plans, risk assessments, and supplier qualifications while ensuring compliance with ISO 9001, ISO 13485, and 21 CFR 820.

Experience with audits by customers and regulators, plus strong English communication and proficiency in MS Office, are essential.