Job Archives

Full Time
Berlin, CT
Posted 6 days ago

TOMZ Corporation is looking to hire a Sr. Quality Engineer – Sustained Manufacturing to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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

This position will be responsible for the activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Fast-paced work environment.

Essential Functions

  • Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
  • Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Ensure the continuous efficiency and improvement of Test/Inspection Methods
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs.
  • Other responsibilities required as outlined in full job description.

Qualifications:

Education

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

TOMZ Corporation is looking to hire a Sr. Quality Engineer – Sustained Manufacturing to join our organization. A leader in manufacturing of devices and components for major medical device companies,...

Full Time
Berlin, CT
Posted 6 days ago

TOMZ Corporation is in search of a Quality Inspector to join our team! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Some of those include 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 the Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components · Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques. Faced paced work environment.

Essential Functions

  • Perform and provide training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
  • Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
  • 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.
  • Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
  • Other duties as required as outlined in full job description.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

  • Minimum of 3-5 years’ experience in a regulated manufacturing environment.

TOMZ Corporation is in search of a Quality Inspector to join our team! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and ...

Full Time
Berlin, CT
Posted 6 days ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector 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 successful candidate will be expected to perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Technical Skills

  • Inspection Techniques: Proficiency in using various inspection methods like comparators, CMMs, microscopes, calipers, micrometers, and gauges.
  • Documentation: Ability to accurately complete and compile quality inspection documents according to established standards.
  • Material Control: Understanding of proper material identification and traceability throughout manufacturing processes.
  • Document Review: Familiarity with reviewing and ensuring Good Document Practices (GDP) for Routers, Inspection Plans, and Device History Records (DHRs).
  • Quality Systems: Experience using ERP and QMS systems for documenting and controlling inspection and traceability activities.
  • Packaging & Documentation: Knowledge of generating Packing Slips and Certificates of Compliance (C of C) according to requirements.
  • Records Management: Familiarity with physical and electronic record retention procedures.

Other Skills

  • Attention to Detail: Demonstrated ability to work meticulously and accurately.
  • Problem-Solving: Skill in identifying and resolving quality issues with machined components.
  • Communication: Effective communication skills to interact with colleagues, supervisors, and customers.
  • Safety: Commitment to following occupational safety and health requirements, including PPE use.

Additional Notes

  • The specific requirements of the role may vary depending on the company and industry.
  • Familiarity with the relevant regulations and standards for the industry is a plus.
  • Candidates with experience in the manufacturing environment will be at an advantage.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

  • Minimum of 3-5 years’ experience in a regulated manufacturing environment.

Qualifications

  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Ability to effectively read and understand blueprints, specifications and procedures.
  • Knowledge of dimensional, visual and mechanical inspection processes.
  • Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
  • 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.
  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Knowledge of and experience with GMP/ISO standards.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector to join our organization. TOMZ offers competitive compensat...

Full Time
Big Lake, MN
Posted 2 weeks ago

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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 the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

  • Manage and coordinate activities related to the development, documentation, and validation of medical devices.
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
  • Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
  • Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
  • Prepares and presents project status reports to internal and external stakeholders.
  • Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

  • 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
  • Experience in manufacturing in a regulated engineering/manufacturing environment.
  • Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation...

Full Time
Knightstown, IN
Posted 4 weeks ago

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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 the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

  • Manage and coordinate activities related to the development, documentation, and validation of medical devices.
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
  • Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
  • Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
  • Prepares and presents project status reports to internal and external stakeholders.
  • Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

  • 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
  • Experience in manufacturing in a regulated engineering/manufacturing environment.
  • Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation...

Full Time
Berlin, CT
Posted 4 weeks ago

TOMZ Corporation, is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. These include 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 the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables in a fast-paced work environment.

Qualifications:

4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience

  • Experience in manufacturing in a regulated engineering/manufacturing environment.

TOMZ Corporation, is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensatio...

Full Time
Big Lake, MN
Posted 1 month ago

TOMZ Corporation is looking for a motivated Application Engineer to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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 certified to ISO 13485.

Summary of Position

Support the organization’s Turning, Milling and Grinding operations of complex medical devices through new development projects as well as optimization of existing legacy programs. Work in cross functional teams to drive continuous improvement and ensure production objectives are met; including but not limited to programming for new product development, optimization of legacy programs for improved throughput, standardization of programs to current best practices, and research and implementation of new tooling and process technology. TOMZ is a fast-paced work environment.

Essential Functions

Duties and responsibilities include, but are not limited to:

  • Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
  • Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities.
  • Actively participate in process development projects and DFM with internal and external teams
  • Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates.
  • Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
  • Machine set-up skills required to accomplish 1st article parts and short run NPI products. With an occasional small production run if needed.
  • Design fixtures for post processing operations.
  • Additional responsibilities as outlined in full job description.

Qualifications:

Education

  • Associate degree in technical or scientific field or equivalent work experience.

Experience

  • Minimum of 5 years’ experience of programming and machine set-up in a medical device manufacturing environment or similar.

TOMZ Corporation is looking for a motivated Application Engineer to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competiti...

Full Time
Berlin, CT
Posted 1 month ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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 manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
  • Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
  • Ability to setup basic legacy components and ensure the machine is ready for steady production.
  • Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
  • Regularly and as prescribed, perform preventive maintenance of equipment.
  • Drive problem solving activities for basic machine or process issues.
  • 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 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.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • Certification from a technical school program preferred.

Experience

  • Minimum of 1-3 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

  • 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.
  • Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
  • Ability to use basic hand-held tools to perform preventive maintenance 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.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.

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 30 pounds while moving tooling or tool holders. 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.

#SJ24

Second Shift: 5:30PM-4:00AM
50 hours

Job Features

Job Category

Second Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II to join our organization. TOMZ offers competitive compensati...

Full Time
Knightstown, IN
Posted 1 month ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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 manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Williemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
  • Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
  • Ability to setup basic legacy components and ensure the machine is ready for steady production.
  • Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
  • Regularly and as prescribed, perform preventive maintenance of equipment.
  • Drive problem solving activities for basic machine or process issues.
  • 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 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.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • Certification from a technical school program preferred.

Experience

  • Minimum of 1-3 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

  • 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.
  • Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
  • Ability to use basic hand-held tools to perform preventive maintenance 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.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.

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 30 pounds while moving tooling or tool holders. 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.

#SJ24

2nd shift: Monday- Thursday 3:30PM- 2:00AM
Weekend shift: Friday- Sunday 6:00AM-6:00PM

Job Features

Job Category

Second Shift, Weekend Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II to join our organization. TOMZ offers competitive compensati...

Full Time
Berlin, CT
Posted 1 month ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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.

Shift: Fri-Sun; 6 am to 6 pm (paid lunch), 15% shift differential

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
  • Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
  • Ability to setup basic legacy components and ensure the machine is ready for steady production.
  • Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
  • Regularly and as prescribed, perform preventive maintenance of equipment.
  • Drive problem solving activities for basic machine or process issues.
  • 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 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.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • Certification from a technical school program preferred.

Experience

  • Minimum of 2-3 years’ experience in a regulated manufacturing environment.

Qualifications

  • 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.
  • Demonstrated understanding of the usage and care of mechanical equipment and inspection processes
  • Ability to use basic hand-held tools to perform preventive maintenance 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.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.

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 30 pounds while moving tooling or tool holders. 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.

Friday-Sunday: 6am to 6 pm with a paid lunch
36 (over time available)

Job Features

Job Category

Weekend Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II to join our organization. TOMZ offers competitive compensati...

Full Time
Berlin, CT
Posted 1 month ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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 manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
  • Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
  • Ability to setup basic legacy components and ensure the machine is ready for steady production.
  • Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
  • Regularly and as prescribed, perform preventive maintenance of equipment.
  • Drive problem solving activities for basic machine or process issues.
  • 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 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.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • Certification from a technical school program preferred.

Experience

  • Minimum of 1-3 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

  • 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.
  • Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
  • Ability to use basic hand-held tools to perform preventive maintenance 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.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.

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 30 pounds while moving tooling or tool holders. 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.

First Shift: Mon-Fri 6 am to 4:30 pm
50 hours

Job Features

Job Category

First Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II to join our organization. TOMZ offers competitive compensati...

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector 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 quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques.
  • Perform and provide training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
  • Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
  • 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.
  • Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
  • 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.
  • Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
  • Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
  • Support physical and/or electronic record retention.
  • 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 3-5 years’ experience in a regulated manufacturing environment.

Qualifications

  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Ability to effectively read and understand blueprints, specifications and procedures.
  • Knowledge of dimensional, visual and mechanical inspection processes.
  • Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
  • 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.
  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Knowledge of and experience with GMP/ISO standards.

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 occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 20 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.

Job Features

Job Category

Second Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector to join our organization. TOMZ offers competitive compensat...