TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Maintenance Machine Specialist 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
The purpose of the Senior Maintenance Machine Specialist is to provide production equipment support for all equipment allocated to the Factory as well as to assist engineering with production-related projects. Routinely works with Plant Maintenance to coordinate jobs and projects. The Senior Maintenance Machine Specialist will take the lead in the implementation and the decision-making process on best practices for the maintenance group. The position is also responsible for creating solutions and providing technical support to enhance production reliability through concerted efforts with cross functional teams.
Essential Functions
- Prepare and process components through various metal finishing operations.
- Tumbling
- Blasting
- Heat Treat
- Laser Welding
- Laser Marking
- Passivation
- Anodize
- Perform visual and basic dimensional inspections on completed components, as required using micrometers, calipers, microscope, 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.
- Other duties and responsibilities are assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 0-2 years’ experience in a regulated manufacturing environment.
Qualifications
- Ability to use basic hand-held tools to support preventive maintenance activities.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Strong verbal and written English language communication skills.
- Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
- Must have good organizational skills.
Preferred Skills
- Ability to effectively read and understand blueprints, specifications, and procedures.
- Knowledge of and experience with GMP/ISO standards.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Class I, II and/or III Medical Device manufacturing experience.
Physical Demands
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.