CNC Cell Lead

TOMZ Manufacturing Corp•Big Lake, MN

10h

About The Position

SUMMARY OF POSITION: Reporting to Department 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. ESSENTIAL FUNCTIONS: 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

Requirements

High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)
Minimum of 3-5 years’ experience in a regulated manufacturing environment
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

Nice To Haves

Certification from a technical school program strongly preferred
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

Responsibilities

Maintain the ISO 13485 standards documentation
Setup and operate equipment
Perform visual and dimensional inspections
Support development of machined components
Be knowledgeable of, and adhere to, the TOMZ Quality Management System
Coordinate the execution of operational objectives within the department
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
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