Join Us on Our Mission to Improve Patients' Lives.

tomzhiring | TOMZ Corporation
Full Time
Berlin, CT
Posted 2 weeks ago

Summary of Position

The Production Planner is responsible for assisting the Master Scheduler and the Supply Chain team to consistently meet customer expectations for delivery and service by effectively utilizing available shop capacity and resources and maintaining a balanced flow of material throughout the facility.

Essential Functions

  • Responsible for loading and balancing the production schedule across multiple work-center groups and departments.
  • Set clear, achievable delivery commitments for internal and external customers.
  • Track planned work orders and adjust the schedule to account for any production issues that directly impact the timing of completion.
  • Analyze resource capacity and efficiently load each production machine and work center to maintain a consistent flow of product throughout the facility.
  • Support the S&OP process by continuous review of production performance and adherence to the master schedule, inventory status, and capacity utilization.
  • Maintain finished goods inventory at target levels to ensure high service levels for Vendor Managed Inventory (VMI). Monitor and adjust WIP and Finished Goods inventory levels on an ongoing basis to meet inventory turn goals.
  • Collaborate with the Manufacturing Managers and the Master Scheduler to meet plant performance goals and objectives.
  • Report key metrics as requested by senior management.
  • Adhere to the TOMZ Quality Management System.
  • Perform other duties as assigned.

Qualifications:

Education

  • BS/BA in Supply Chain, Business (desired) , or equivalent combination of education and planning experience.

Experience

  • 2-3 years of experience in a production planning role working for a direct manufacturer (required)

Qualifications

  • Minimum 1 year of experience planning in a machining environment, preferably in an ISO 13485 certified facility.
  • ERP / MRP experience in Epicor or similar ERP software.
  • Proficient with the MS Office suite – advanced skills with MS Excel.
  • APICS certification (CPIM or CSCP) preferred.

Preferred Skills

  • Business Administration, Supply Chain, Logistics, Operations knowledge.
  • Strong sense of urgency & attention to detail.
  • Ability to take constructive guidance on planning preferences.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift to 25 pounds. Team lift or mechanical assistance required for objects over 25 pounds.
  • Perform keyboard entries with frequent operation of a computer.
  • Ability to use power tools as needed.
  • As needed to comply with safety requirements - need to wear safety equipment such as cut-resistant gloves, safety glasses, hearing protection, steel-toe, and slip-resistant shoes.

Summary of Position The Production Planner is responsible for assisting the Master Scheduler and the Supply Chain team to consistently meet customer expectations for delivery and service by effectivel...

Full Time
Berlin, CT
Posted 2 weeks ago

Summary of Position

Reporting to the Department Manager, this position is primarily responsible for working in a functional Scheduling and Planning group. Working with a combination of firm orders, customer forecasts, and internal forecasting, the candidate will be able to create a complete schedule plan for manufacturing that will meet the delivery needs of the customer and optimize the capacity and workflow of manufacturing for multiple sites.

Essential Functions

  • Capable of establishing an S&OP program, defining operating procedures, and establishing an S&OP planning team from different parts of an organization.
  • Assemble master schedule reporting regarding performance to the business plan, the shipment plan, the inventory plan and the production plan.
  • Maintain and communicate production schedules across 3 business sites.
  • Communicate changes to production teams affected by schedule changes.
  • Understand output of materials requirement planning (MRP), capacity management, and advanced planning system technologies.
  • Possess a full understanding of modern planning concepts and practices.
  • Be capable of utilizing spreadsheet and ERP-type software in managing the planning process.
  • Understand and manage make-to-stock, make-to-order, assemble-to-order, and engineer-to-order manufacturing requirements.
  • Calculate production lead times.
  • Have knowledge of how to level load a production schedule and handle bottleneck scheduling.
  • Effectively analyze whether inventories need to be maintained, increased, or decreased.
  • Be capable of scheduling demand based on the product mix.
  • Identify parts that would be good candidates for safety stock and use ERP system to manage inventory associated.
  • Manage schedule changes through system generated action messages.
  • Be capable of translating the production plan into a time-phased build schedule.
  • Coordinate information with other functional staff including sales, engineering, accounting and finance as needed.
  • Ability to accept change and work well in a high pressure environment.
  • Identify opportunities for improvements and drive change in the organization.
  • Own the production schedule from order entry to shipment.
  • Periodic travel as necessary.

Qualifications:

Education

  • A bachelor’s degree in business, Supply Chain, or equivalent with 5 years of relevant experience; Or the equivalent combination of experience and education.
  • APICS or ISM certification desirable.

Qualifications

  • Experience in a regulated manufacturing environment preferred (preferably in a Medical Device or Aerospace Manufacturer).
  • Excellent verbal and written communication skills.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Strong computer skills, including the MS Office suite. Experience with Epicor desirable.
  • Must understand capacity management within MRP environment.
  • Strong analytical skills, must be able to obtain data, evaluate, and apply planning principles from multiple sources.
  • Ability to work with a remote team in a collaborative environment across multiple departments and sites.

Summary of Position Reporting to the Department Manager, this position is primarily responsible for working in a functional Scheduling and Planning group. Working with a combination of firm orders, cu...

Full Time
Big Lake, MN
Posted 4 weeks ago

Summary of Position

Reporting to the Quality Engineering Manager, this position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions

  • Develop and execute Quality Plans for Quality Product Design and Development projects.
  • Collaborate with engineering teams to initiate and support the development and updates of Risk Management documentation in accordance with project requirements.
  • Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
  • Support operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
  • Drive Test Method development with Operational and Business considerations and execution of Test Method Validations to measure effectiveness.
  • Implement inspection plans for Incoming, In-Process and Final Product.
  • Develop and justify appropriate sampling plans with characterization of test and inspection methods.
  • Represent Quality Engineering in design reviews.
  • Support initial qualification audit activities for Customer and Regulatory Agencies.
  • Support qualification activities related to supplier and vendor design characterization requirements for projects, including conducting audits and assessments.
  • Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
  • Apply sound, systematic problem-solving methods in identifying, prioritizing, communicating, and resolving quality issues.
  • Ensure that all site personnel comply with the site-level Quality Management System and training requirements.
  • Support the development of Quality Agreements for external customers.
  • Adhere to the TOMZ Quality Management System.
  • Perform other duties as assigned.

Qualifications:

Education

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

Experience

  • Minimum of 2-5 years’ experience in a regulated manufacturing environment.
  • Experience in Class I, II, and/or III medical device manufacturing within a regulated environment (e.g., Aerospace, Defense, Pharmaceutical, etc.).

Qualifications

  • Advanced Post-Secondary Education, Training or Certification coursework.
  • Knowledge of statistical techniques to analyze process capability.
  • Quality certification(s) (e.g., ASQ CQE, QCI, etc.).
  • Skilled in First Article Inspections and Component Qualifications.
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, 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 and functional on-the-job training requirements.
  • Proficiency with Microsoft Office.
  • A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
  • Ability to sit for prolonged periods.
  • Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
  • Perform keyboard entries with frequent operation of a computer.

Pay Range: $79K - $108K / year

Summary of Position Reporting to the Quality Engineering Manager, this position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance...

Full Time
Big Lake, MN
Posted 4 weeks ago

TOMZ Corporation, a leader in the manufacturing of devices and components for major medical device companies, is looking for a Human Resources Assistant 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 HR Generalist will be responsible for applying human resources expertise in several areas of HR and assist in providing a wide range of support to the business. The successful candidate will play a key role in the administration, organization, and success of the HR Department by providing support to the Director and guidance on employee on basic company related information.

*No relocation is being offered for this role.

Essential Functions

  • Responsible for new employees on their first day, tasks include taking employee badge photos, verifying paperwork, Orientation and ordering lunch.
  • Prepare new hire paperwork, scan, file and track all new hire paperwork.
  • Assist employees with questions on various benefits websites; Health Insurance, Safety Shoes, and TOMZ Apparel.
  • Ensure that all new hire onboarding paperwork, transfer and promotion paperwork is completed and turned in on time.
  • Administer employee referral bonuses.
  • Audit and track all employee paperwork for compliance.
  • Handles administrative tasks for department, files and processes terminations related to employee files.
  • Understand Form I-9, maintain historical I-9’s and assist with obtaining new documentation as needed.
  • Assist Employee Relations Specialist with the community projects and programs such as employee recognition, wellness, and company events.
  • Post and distribute internal communications, information, and materials.
  • Maintain employee bulletin board, Wellness Board and Anniversary Board in CT.
  • Maintains and updates OSHA Log.
  • Able to back-up to assist with Recruiting as necessary.

If Bi-lingual:

  • Will be responsible for coordinating and conducting HR Orientation, Safety Orientation and Quality Systems Orientations.
  • Translate other employee questions as necessary.
  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System. Responsible for compliance of Human Resources records in relationship the Quality Management System.
  • Other duties as assigned.

Qualifications:

Education and Experience

  • Bachelor’s degree in human resources or relevant experience.
  • 5+ years in a Generalist Role.

Qualifications

  • Ability to maintain confidentiality and professionalism.
  • Proficiency with Microsoft Office (Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint).
  • Understanding of personnel and compliance records management.
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong level of attention to detail.
  • Ability to work independently or collaboratively.

Preferred Skills

  • Highly preferred: Bi-lingual in Ukrainian and Polish languages.
  • OSHA reporting compliance.

Pay Range: $27 - $38 / hour

TOMZ Corporation, a leader in the manufacturing of devices and components for major medical device companies, is looking for a Human Resources Assistant to join our organization. TOMZ offers competiti...

Full Time
Big Lake, MN
Posted 4 weeks ago

Summary of Position

Reporting to the Quality Manager this position will be responsible for the activities associated with quality engineering in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms, corrective and preventative action, and creating and refining test methods.

Essential Functions

  • Operates and programs advanced measurement equipment including Vision Systems and CMMs.
  • Authors Inspection Plans and defines process controls.
  • Collaborates and defines Test Method.
  • Knowledge of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go gages and No-Go gages.
  • Execution and evaluation of Test Method Validations.
  • Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
  • Initiate and consult in the development and update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
  • Collaborates to develop Process Master Validation Plans.
  • Performs process qualifications, analyzes data and initiates corrections or corrective actions as required.
  • Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans.
  • Champion First Article Inspections.
  • Support Gage calibration review, management, execution and evaluation.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues through the CAPA process.
  • Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers and product families.
  • Generate ECOs for the release of Quality Engineering documentation.
  • Adhere to the TOMZ Quality Management System.
  • Perform other duties as assigned.

Qualifications:

Education

  • Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.

Experience

  • Minimum of 0-2 years’ experience in a regulated manufacturing environment.
  • Prior relevant internship experience preferred.

Qualifications

  • Demonstrated self-starter with ability to work in a fast-paced environment.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
  • Strong verbal and written English language communication skills.
  • Basic understanding of statistical techniques and sampling strategies

Preferred Skills

  • ASQ-CQT, CQE or CRE preferred.
  • Certification in GD&T preferred
  • Certifications in DMIS programming preferred
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)

Travel Requirements

  • Travel outside the workplace is required for up to 15% of the year.
  • Travel may include multiple overnight stays and may occasionally require weekend commitments.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 30 pounds. Team lift or mechanical assistance required for objects over 30 pounds.
  • Ability to sit for prolonged periods.
  • Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
  • Perform keyboard entries with frequent operation of a computer.

Pay Range: $65K - $96K / year

Summary of Position Reporting to the Quality Manager this position will be responsible for the activities associated with quality engineering in a medical device manufacturing environment. This includ...

Full Time
Berlin, CT
Posted 4 weeks ago

Summary of Position

Reporting to the Department 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

  • 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.

Summary of Position Reporting to the Department Manager, this position will have direct responsibility for the processing of parts through various functions within the Department. TOMZ manufactures pa...

Full Time
Big Lake, MN
Posted 2 months ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Shipping and Receiving Technician to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which 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 Supply Chain Manager, this position is responsible for supporting operations with product flow as needed. TOMZ corporation, a company specializing in high-precision metal machining, finishing, assembly, and anodizing for Medical Devices. The successful candidate will maintain the highest level of traceability in handling the receipt, storage, and issuance of raw materials, ensuring smooth support for manufacturing processes while adhering to regulatory and quality standards.

Essential Functions

  • Receipt and incoming inspection of all raw materials.
  • Appropriate storage of all raw materials including ERP transactions and physical locations.
  • Issue raw materials to manufacturing operations.
  • Perform and document routine cycle counts to ensure proper inventory levels are maintained.
  • Print Job Travelers as required to support production flow.
  • Perform the “SAW” operation for all required materials prior to issuing to production floor.
  • Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
  • Monitor and order office and shop supplies.
  • Order production tooling and enter into inventory when received.
  • Support manufacturing as needed.
  • Adhere to the TOMZ Quality Management System.
  • Perform other duties as 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.

Qualifications

  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Demonstrated ability to manage inventory levels.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Ability to use basic hand-held tools and inspection equipment to support receiving inspection activities.
  • Forklift training required.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
  • Perform keyboard entries with possible frequent operation of a computer.
  • Ability to use power tools as needed.
  • As needed to comply with safety requirements - need to wear safety equipment such as cut resistant gloves, safety glasses, hearing protection, steel toe and slip resistant shoes.

Pay Range: $21/hr - $28/hr

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Shipping and Receiving Technician to join our organization! ...

Full Time
Big Lake, MN
Posted 2 months ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Machine Maintenance 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 Machine Maintenance 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 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

Duties and responsibilities include, but are not limited to:

  • Adherence to all department safety measures and work instructions.
  • Accountable for personal safety, the safety of co-workers and promoting a safe work environment.
  • Repair and maintain all production equipment, both electrical and mechanical.
  • Assist engineering as required with special machine related projects.
  • Work with CONC and PLC controlled machines.
  • Routinely work in electrical control panels of production equipment to troubleshoot electrical problems.
  • Arc Flash certified worker to work “live” electrical control panels.
  • Working understanding of precision measuring instruments used in troubleshooting.
  • Read and interpret diagrams, schematics and specifications related to equipment operation.
  • Monitor, modify, or write programmable ladder logic circuits as needed for existing or new installations.
  • Create electrical drawings, PLC programs to be used for troubleshooting of modified equipment.
  • Install electrical, air and data drops to equipment and machines.
  • Work with outside contractors for equipment repair of production machines as needed and verify completion accuracy.
  • Design and implement electrical circuits and technologies for support of production equipment.
  • Initiate or enhance the preventative maintenance schedules for production equipment.
  • Calibrate equipment using general and special purpose test equipment.
  • Facilitate equipment modifications, upgrades, overhauls, and root cause failure analyses.
  • Ensure respective area is complaint with 5S Standards.
  • Maintain daily log of work in established systems.
  • Support ISO 13485 initiatives.
  • Assist in training individuals with less experience and tenure on established maintenance standards and practices.
  • Project initiation and improvement ideas to better production and the business.
  • Purchase repair parts, tools, and supplies in appropriate ERP software.
  • Provide input for annual department budget planning.
  • Ability to work flexible hours (including overtime) to accommodate production working hours as needed.
  • Other duties and responsibilities as assigned.

Qualifications:

Education

  • Associate degree in a technical related field or equivalent experience

Experience

  • Minimum 10 years’ experience in the Equipment Maintenance Field

Qualifications

  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Maintains accuracy, is detail oriented, and completes tasks in a timely manner.
  • Prior experience with CNC and PLC controlled equipment.
  • Experience with MS Office Programs.
  • Ability to perform routine maintenance of CNC manufacturing equipment; troubleshoot issues and support, or directly resolve as appropriate.
  • Ability to read and interpret documents and drawings (e.g., blueprints, manuals, wiring diagrams etc.)
  • Time management skills and ability to prioritize workflow throughout the day.
  • Strong verbal and written English language communication skills.

Preferred Skills

  • Forklift and OSHA Training.

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 tooling, fixtures, equipment and/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.

Pay Range: $29.81/hr - $43.75/hr

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Machine Maintenance Specialist to join our organization. TOMZ offers c...

Full Time
Fishers, IN
Posted 3 months ago

Join our team in Fishers, Indiana! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Staff Quality Engineer 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 certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Engineering, Control and Assurance continuation development support for continuous improvement of manufacturing processes.

Essential Functions

  • Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans.
  • Leads on strategic initiatives to improve Quality Processes and Systems.
  • Owns the development and/or update of Risk Management files in cooperation with cross-functional engineering teams, operations and customers.
  • Supports the procurement and qualification of capital equipment.
  • Operates and programs advanced measurement equipment including Vision Systems and CMMs.
  • Authors Inspection Plans and defines process controls. Defines Test Method.
  • Subject Matter expertise of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
  • Execution and evaluation of Test Method Validations.
  • Creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
  • Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
  • Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, resolving quality issues through the CAPA process.
  • Defines and Measures KPI’s for New Product Introduction.
  • Interfaces with the customer and meets all defined deliverables.
  • Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
  • Generate ECOs for the release of Quality Engineering documentation.

Qualifications:

Education/Experience

  • Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
  • Minimum of 0-4 years’ experience in a regulated manufacturing environment.
  • Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (12+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)

Qualifications

  • Ability to travel up to 20%.
  • Demonstrated self-starter with ability to work in a fast-paced environment.
  • Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint)
  • Strong verbal and technical writing capabilities (English language).
  • Expertise is statistical techniques, GD&T, process validation, and Metrology.
  • Demonstrated ability to work in and lead teams through large scale projects.

Preferred Skills

  • ASQ CQE or CRE.
  • Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
  • Six Sigma Green or Black belt.
  • Certifications in DMIS programming preferred
  • Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience. (exp: Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 9000/9001, 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).

Join our team in Fishers, Indiana! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Staff Quality Engineer to...

Full Time
Berlin, CT
Posted 3 months ago

Summary of Position

Join our team in Berlin, CT!! Reporting to the Engineering Manager, the Manufacturing Engineer will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommends and improvements to sustained production processes, methods, and controls, as well as coordinate the launch of new products into volume production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Essential Functions

  • Support Production in reducing / eliminating equipment and tooling downtime or scrap.
  • Perform tool life studies to drive efficiency and cost savings opportunities.
  • Conduct Process Capability studies during manufacturing processes to support achieving objectives.
  • Collaborates with cross-functional teams during the production transfer phase to establish and launch robust, mid to high volume processes.
  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

Education

  • Minimum of a bachelor’s degree in an engineering discipline or equivalent experience.

Experience

  • Minimum of 5 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace contract Manufacturer).

Qualifications

  • Must possess a high attention to detail.
  • Ability to read drawings and specifications containing GD&T.
  • Proficiency in SolidWorks.
  • Proficient in the use of Microsoft Office and Adobe products.
  • Solid knowledge of GMP and ISO 13485 regulations.
  • Experience with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles.
  • Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.

TOMZ Corporation is an Equal Opportunity Employer

Summary of Position Join our team in Berlin, CT!! Reporting to the Engineering Manager, the Manufacturing Engineer will have direct responsibility for developing and implementing robust cost-effective...

Our Mission

Advancing quality of life by manufacturing medical devices for global healthcare companies.

Group photo of the TOMZ Corporation team standing next to a white sports car with the blue and red TOMZ Corporation logo on it in front of the company's headquarters in Berlin, Connecticut.
Green and blue specialty screws that are created at the TOMZ Corporation for use in medical devices.

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.

X-ray showing two views of a spinal fusion that was done using hardware manufactured at TOMZ Corporation.
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.
Three women employees, two wearing blue shirts and one wearing a white shirt and blue latex gloves, stand at a table as they smile and perform quality control inspections on specialty screws and other manufactured parts.
Embrace Diversity
Our workforce is incredibly diverse by design. Individuals from different backgrounds offer valuable, unique perspectives. Diversity leads to innovation and open-mindedness.
Three employees, two wearing blue shirts and one wearing a red shirt, stand next to a microscope in the machine shop as they look closely at a manufactured part.
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.
An employee stands in front of a yellow background that says he's won the prize of a week's paid vacation and a $5,000 travel voucher as he holds onto an oversized check stating the same. Other employees in the audience cheer him on.

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

Playlist

2 Videos

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

Enjoy 9 paid holidays off per year.

Paid Time Off (PTO)

PTO starts accruing from the day you start.

Referral Bonus

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!

Quarterly Bonus

Teams achieving set performance goals receive a quarterly performance bonus.