Application Engineer

Tomz Corporation•Berlin, CT

46d•$65,000 - $120,000•Onsite

About The Position

TOMZ Corporation is looking for a highly motivated Quality Engineer to join our team in Berlin, CT!! Reporting to the Quality Engineering Manager, this position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Requirements

Advanced Post-Secondary Education, Training or Certification coursework.
Knowledge of statistical techniques to analyze process capability.
Quality certification(s) (e.g., ASQ CQE, QCI, etc.).
Skilled in First Article Inspections and Component Qualifications.
Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
Experience in effectively supporting audits by customers and external regulatory agencies.
Strong verbal and written English language communication skills.
Successfully meet TOMZ-specific positional and functional on-the-job training requirements.
Proficiency with Microsoft Office.
A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results.
Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Experience in Class I, II, and/or III medical device manufacturing within a regulated environment (e.g., Aerospace, Defense, Pharmaceutical, etc.).

Responsibilities

Develop and execute Quality Plans for Quality Product Design and Development projects.
Collaborate with engineering teams to initiate and support the development and updates of Risk Management documentation in accordance with project requirements.
Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
Support operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
Drive Test Method development with Operational and Business considerations and execution of Test Method Validations to measure effectiveness.
Implement inspection plans for Incoming, In-Process and Final Product.
Develop and justify appropriate sampling plans with characterization of test and inspection methods.
Represent Quality Engineering in design reviews.
Support initial qualification audit activities for Customer and Regulatory Agencies.
Support qualification activities related to supplier and vendor design characterization requirements for projects, including conducting audits and assessments.
Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
Apply sound, systematic problem-solving methods in identifying, prioritizing, communicating, and resolving quality issues.
Ensure that all site personnel comply with the site-level Quality Management System and training requirements.
Support the development of Quality Agreements for external customers.
Adhere to the TOMZ Quality Management System.
Perform other duties as assigned.