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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Cell Leader 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 Supervisor or Operations Manager, this position will have direct responsibility for the output and efficiency for the manufacture/processing of components within a 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, perform visual and dimensional inspections, and support development of machined components.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Ability to coordinate the execution of operational objectives within the department. Ex. low scrap rates, high efficiency and output, schedule adherence, etc.
- Train/Coach standard best practices for setup/operation of equipment across all technical levels and ensure that employees are scheduled appropriately according to skill level and ability.
- Support the setup and operation of equipment within a cell by pulling the appropriate resources, as needed, to minimize downtime and increase output.
- 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.
- Drive problem solving activities for complex machine or process issues and assign appropriate resources to the efforts.
- Review product/process standards are accurate and achieved within the department.
- 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 3-5 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.)
- Demonstrated coaching or training skills to drive departmental and company objectives.
- 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.
- 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.