Job Description

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Metrology Specialist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 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 Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION:

This position will be responsible for the activities associated with developing advanced metrology methods in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms, corrective / preventative action, and creating and refining test methods

ESSENTIAL FUNCTIONS:

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Operates and programs advanced measurement equipment including Vision Systems, CMMs, PLCs, Optical Sensors, Contracers and Laser Measurement Systems.
• Acts as the Subject Matter Expert in GD&T
• Uses expertise in bench layouts to resolve complex measurement challenges.
• Collaborates and defines Test Method.
• Expertise of precision measuring instruments and their application, including but not limited to, Electronic height gages, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Design, Model and Build inspection work holding fixtures.
• Additional requirements as outlined in full job description.

QUALIFICATIONS:

Education/Experience

• Technical training in GD&T and measurement programing system.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Minimum of 3 years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming.

Qualifications

• Ability to travel up to 5%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
• Strong verbal and written English language communication skills.
• Basic understanding of statistical techniques and sampling strategies

Preferred skills

• ASQ-CQT, CQE or CRE preferred.
• Certifications in DMIS programming preferred
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially 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).

TOMZ is an Equal Opportunity Employer

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