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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator II 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 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.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Prepare and process components through various metal finishing operations. Ex. include operation of manual sand blasting equipment, fixturing and operation of laser marking equipment, fixturing and operation of laser welding equipment, loading and un-loading heat treat-furnace, etc.
- Perform visual and basic dimensional inspections on completed components, as required, using micrometers, calipers, microscope, etc.
- Complete and compile 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.
- Other duties and responsibilities are assigned.
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline 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.
- 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.
- 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 components or fixtures/racking. 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.