**Summary of Position:

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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:

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Operates and programs advanced measurement equipment including Vision Systems, CMMs, PLCs, Optical Sensors, Contractors, 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.
Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans.
Champion First Article Inspections.
Support Gage calibration review, management, execution, and evaluation.
Establish standards for Gage Calibration.
Competency with materials testing chemistry and mechanical testing.
Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
Reviews ECOs for the release of Quality Engineering documentation.
Creates inspection instructions.
Adhere to the TOMZ Quality Management System.
Perform other duties as assigned.

**Qualifications:

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Demonstrated self-starter with ability to work in a fast-paced environment.
Competency with Microsoft Office
Strong verbal and written English language communication skills.
Basic understanding of statistical techniques and sampling strategies

**Experience:

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Minimum of 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.
3+ years training in GD&T and measurement programing system.

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**Education:

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High School Diploma or GED

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**Preferred skills:

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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).

**Travel Requirements:

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Travel outside of the workplace is required for up to 5% of the year.
Travel may include multiple overnight stays and may occasionally require weekend commitments.

**Physical Requirements:

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Ability to bend, stoop, squat, kneel, and lift up to 30 pounds. Team lift or mechanical assistance required for objects over 30 pounds.
Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
Ability to sit for prolonged periods.
Proficient use of a keyboard and mouse, requiring manual dexterity and coordination.
Ability to focus on a computer screen and other visual tasks for prolonged periods, with appropriate vision correction if needed.
Perform repetitive hand and arm movements.