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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Manufacturing Support Technician 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 as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
SUMMARY OF POSITION:
Reporting to Department Manager, this position will have direct responsibility for the preparation and support of the production readiness checklist within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, prepare setup sheets, inspection plans, tooling and work holding and distribute material prior to setup, as well as perform basic routine maintenance and repair of production equipment.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Ensure that proper material control, along with identification and traceability, is maintained for conforming and nonconforming material through the manufacturing processes.
- Utilize and navigate ERP and QMS systems to ensure proper inspection plans and setup sheets are provided to machinist as part of production readiness prior to scheduled setup.
- Demonstrated ability to preset tooling and take basic measurements of tooling geometry.
- Perform visual and dimensional inspections of tooling and work holding, as required using tooling pre-setter, microscope, micrometer, caliper, pin gages, comparator, etc.
- Monitor tool life and usability for tooling being returned from a production run.
- Ability to read and understand basic machine schematics and manuals to perform preventive maintenance and basic repairs on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
- Regularly, and as prescribed, perform preventive maintenance of equipment.
- Coordinate service or support for problem solving activities or complex machine or process issues.
- Completes and compiles necessary documentation related to Quality Inspection standards.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Other duties and responsibilities as assigned.
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Certification from a technical school program strongly preferred.
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge of and experience with GMP/ISO standards.
- Advanced understanding of the usage and care of mechanical equipment and inspection processes.
- Ability to use hand-held tools to perform preventive maintenance or repair activities and prepare, install, or change tools.
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to effectively read and understand machine schematics, blueprints, specifications, and procedures.
- Always maintains accuracy and attention to detail and completes tasks in a timely manner.
- Strong verbal and written English language communication skills.
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 frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving tooling, tool holders, or equipment replacement parts. 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.