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Quality Engineer

2 months ago


New York, United States Tomz Full time

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485. SUMMARY OF POSITION: 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. ESSENTIAL FUNCTIONS: Must be knowledgeable of, and adhere to, the TOMZ Quality Management System. Author and execute Quality Plans for Quality Product Design and Development projects. Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per 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 cooperation with cross-functional engineering teams per project requirements. Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity. Additional responsibilities as outlined in the full job description. QUALIFICATIONS: Education Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred). Experience Minimum of 4+ years of experience in a regulated manufacturing environment. ***Additional qualifications as outlined in the full job description. TOMZ Corporation is an Equal Opportunity Employer