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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III 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 setup and manufacture of components 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, setup and operate equipment, and perform visual and dimensional inspections on machined components.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Ability to operate and maintain production 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.
- Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
- Ability to efficiently setup complex legacy components and basic new production orders and ensure the machine is ready for steady production.
- Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, Vision system, etc.
- Regularly and as prescribed, perform preventive maintenance of equipment.
- Drive problem solving activities for complex machine or process issues.
- Completes and compiles necessary documentation related to Quality Inspection standards.
- Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
- Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Other duties and responsibilities are 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 3-7 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 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 blueprints, specifications, and procedures.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Strong verbal and written English language communication skills.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
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 30 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.