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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator I 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 automated 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 inspections on completed components.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Prepare components to be processed through various automated metal finishing operations. Ex. include loading and un-loading of automated sand blasting or tumbling equipment, racking and un-racking components to support the anodize and passivation line.
- Perform visual inspections on completed components, as required.
- 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.
- Other duties and responsibilities are assigned.
- High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Minimum of 0-2 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 support preventive maintenance activities.
- Ability to effectively read and understand 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 occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. 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.