Process Operator I

Summary of Position :

Reporting to Department Manager, this position will have direct responsibility for the processing of parts through various functions within the 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 materials to be processed through various operations, and perform basic visual and dimensional inspections on completed components.

Essential Functions :

Prepare and process components through various metal finishing operations.

Tumbling

Blasting

Heat Treat

Laser Welding

Laser Marking

Passivation

Anodize

Perform visual and dimensional inspections on manufactured components, as required using a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, Micro-Hite, etc.

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 follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.

Adhere to the TOMZ Quality Management System.

Perform other duties as assigned.

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.

Strong background concerning the usage and care of mechanical metal finishing equipment and processes.

Ability to use basic hand-held tools to perform preventive maintenance activities.

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.

“Hands-on” self-starter with ability to work both independently and as part of a team.

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

Must demonstrate good organizational skills.

Education :

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience :

Preferred Skills :

Physical Requirements :

Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 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 or stand for prolonged periods.