Job Description

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.

ESSENTIAL FUNCTIONS:

• 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.
• 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.
• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Other duties and responsibilities are assigned

QUALIFICATIONS:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program strongly preferred.

Experience

• Minimum of 3-7 years’ experience in a regulated manufacturing environment.

Qualifications

• 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.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred skills

• Strong verbal and written English language communication skills.

Physical Requirements

• Occasionally lift/move up to 50 pounds this may be performed with assistants if needed.
• Prolonged periods of sitting.

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