Join Us on Our Mission to Improve Patients' Lives.

Full Time
Knightstown, IN
Posted 3 weeks ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Systems Specialist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains modern, clean, and safe facilities 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 position will be responsible for ensuring global operational adherence and compliance to TOMZ’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Essential Functions

  • Lead Quality Management System initiatives and continuous improvement activities.
  • Generate project Quality Plans for the QMS and Organizational Objectives.
  • Facilitate organizational compliance training and continual audit/assessment preparedness.
  • Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Coordinate tracking/trending & reporting of quality system metrics and inputs to Management Review(s).
  • Internal Auditing:
    • Lead efforts to ensure all internal audits are performed as scheduled.
    • Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality Management System, including investigation observations/findings and reporting.
  • Corrective/Preventive Actions (CAPA):
    • Responsible for CAPA system administration, CAPA tracking and trending, and, as necessary, lead CAPA implementation efforts.
  • Supplier Quality Management:
    • Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
    • Monitor and facilitate timely execution of Supplier/vendor Corrective Actions (SCAR).
  • Documentation Control:
    • Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
  • Complaints Investigation/Returned Materials Analysis:
    • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control:
    • Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
  • Ensure compliance of all personnel to QMS requirements.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Other duties and responsibilities as assigned.      

Qualifications:

Education

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

Experience

  • Minimum of 4-6 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication skills.
  • Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

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 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.

This position will minimally require intermittent travel between TOMZ Corporation sites and/or supplier facilities within the United States.

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

Full Time
Knightstown, IN
Posted 4 weeks ago

TOMZ Corporation is looking for a Quality Systems Specialist 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 modern, clean, and safe facilities 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 position will be responsible for ensuring global operational adherence and compliance to TOMZ’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Essential Functions

  • Lead Quality Management System initiatives and continuous improvement activities.
  • Generate project Quality Plans for the QMS and Organizational Objectives.
  • Facilitate organizational compliance training and continual audit/assessment preparedness.
  • Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Coordinate tracking/trending & reporting of quality system metrics and inputs to Management Review(s).
  • Internal Auditing:
    • Lead efforts to ensure all internal audits are performed as scheduled.
    • Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality Management System, including investigation observations/findings and reporting.
  • Corrective/Preventive Actions (CAPA):
    • Responsible for CAPA system administration, CAPA tracking and trending, and, as necessary, lead CAPA implementation efforts.
  • Supplier Quality Management:
    • Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
    • Monitor and facilitate timely execution of Supplier/vendor Corrective Actions (SCAR).
  • Documentation Control:
    • Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
  • Complaints Investigation/Returned Materials Analysis:
    • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control:
    • Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
  • Ensure compliance of all personnel to QMS requirements.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Other duties and responsibilities as assigned.      

Qualifications:

Education

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

Experience

  • Minimum of 4-6 years’ experience in a regulated manufacturing environment.

Qualifications

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
  • Experience in effectively supporting audits by customers and external regulatory agencies.

Preferred Skills

  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

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 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.

This position will minimally require intermittent travel between TOMZ Corporation sites and/or supplier facilities within the United States. 

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

Full Time
Berlin, CT
Posted 1 month ago

TOMZ Corporation is looking for a Quality Engineering 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, 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

This position will be responsible for the Leadership and management of site-level Quality Engineering personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System.

Essential Functions

  • This position may have direct-reporting responsibilities for daily activities of Quality personnel.
  • Designated Site-level Management Representative for assurance of compliance to the TOMZ Quality Management System.
  • Drive and support QMS initiatives and continuous improvement activities.
  • Support establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality Engineering, as well as cross-functional teams.
  • Work closely with Engineering and Operations teams to identify and drive actions that reduce the Cost of Poor Quality.
  • Drive integration of new manufacturing capabilities, new test methods and innovation in technology, cost/labor reduction opportunities, product transfers, design transfers and sustained manufacturing customers.
  • Provide Leadership and Guidance for Quality functions including, Product and Process Risk Management, Test Method Selection and Development, Control Point establishment, Risk and Severity-based Sampling Plan, Process Validation Strategy, Complaint Handling/Returns, Corrective/Preventive Actions, and Nonconforming Material Handling.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; trending of associated metrics to drive continuous improvement initiatives.
  • Provide Leadership and Guidance for Development Engineering, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Process FMEAs), Limit Characterization, Inspection Controls, Technical Root Cause Investigation, and resulting Corrective Actions.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees, and performed in compliance with Federal and local laws, as well as TOMZ policies.
  • Other duties and responsibilities as assigned.

Qualifications:

Education

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

Experience

  • Minimum of 1-3 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 5 years of experience in a regulated manufacturing environment.

Qualifications

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Preferred Skills

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

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 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.

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

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

M-F: 5:30pm to 4:00am
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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...

Knightstown, IN
Posted 1 month ago

Reports to: Plant Manager

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator 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 Plant Manager, this position will have direct responsibility for the processing of parts through various 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 and dimensional inspections on completed components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Prepare and process components through various metal finishing operations. Ex. include operation of manual sand blasting equipment, fixturing and operation of laser marking equipment, fixturing and operation of laser welding equipment, loading and un-loading heat treat-furnace, etc.
  • 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 2-5 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.
  • Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
  • Ability to use basic hand-held tools to perform preventive maintenance activities.
  • 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.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
  • 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 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.

Monday- Friday (8 hour shift)

Reports to: Plant Manager TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator II to join our organization. TOMZ offers ...

Our Mission

To enhance the lives of patients by sustainably manufacturing innovative medical devices for leading OEMs around the globe.

We Manufacture Medical Devices

We specialize in manufacturing the best medical device implants for medical teams and surgeons around the world. Most of our team will tell you that the work is very fulfilling because we help people live better lives.

Company Values & Culture

Our DNA is as unique as everyone that works here.

Put Patients First
Surgical teams around the world rely on us to help improve their patient's lives. Our impact is on a global scale and our team members recognize the importance of their work.
Embrace Diversity
Our workforce is incredibly diverse by design. Individuals from different backgrounds offer valuable, unique perspectives. Diversity leads to innovation and open-mindedness.
Learn & Grow
We invest in our people, our facility, and technology to foster an environment of innovation and out-of-the-box thinking. Ideally, we all support the same mission.

Reward Great Effort

We consistently evaluate the work our team members do and reward them not only financially, but with growth opportunities as well. Your goal is our goal.

Why Work at TOMZ?

We are large enough to offer stability and great benefits, yet small enough to recognize you as an individual and not just “another employee.”

Multiple departments from facilities management to engineering allows you to explore different career paths.

The medical devices industry is experiencing explosive growth with no signs of stopping any time soon.

We have completed our 8th expansion which includes amenities such as locker rooms, showers, an expanded cafeteria, and more.

We have a deep bench of knowledgeable pros to help you.

Everything from 401K to top-of-the-line healthcare, life insurance, and more!

What Our Team Members Have to Say

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Benefits

401(k) Retirement Plan

We will match $0.50 on the dollar up to an 8% contribution. Work with us, retire with us.

Overtime Available

Opportunities to earn overtime hours are available as needed.

Paid Holidays

9 paid holidays AND enjoy a half-day the work day before the paid holiday.

Paid Vacation

Paid vacation starts accruing from the day you start.

Referral Bonus

All employees are eligible to earn a $3,500 referral bonus!

Health Insurance Plans

Enjoy a low employee co-pay with high contributions towards your plan.

Dental Insurance Plans

Yes - we have a great dental plan as well!

Annual Bonus

Production teams achieving set performance goals receive an annual performance bonus.