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.
- 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.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Other duties and responsibilities as assigned.
Qualifications:
Education/Experience
- High School Diploma or GED
- 3+ years of 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).
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk, and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
