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tomzhiring | TOMZ Corporation
sign-on bonus for CNC Machinists

Summary of Position

Report directly to quality leadership and take ownership of day-to-day quality control within the department at TOMZ. We manufacture high-precision, metal machined and assembled components with anodize processes for Medical Devices. As the Senior Dimensional Inspection Lead, you’ll keep ISO 13485 documentation current and perform both conventional and advanced inspections across incoming, in-process, and final stages.

A Day in the Life

You start by aligning the team’s priorities, setting measurable targets, and ensuring the right people are on the right inspections. You review Device History Records (DHRs) against the Device Master Record (DMR), confirm Good Documentation Practices (GDP) are being followed on routers, inspection plans, and DHRs, and release finished lots when all criteria are met. Throughout the day you’ll move between departments, tackling complex inspections with comparators, vision systems, and basic CMM operation—training others as you go. When nonconformances surface, you capture them in the ERP/QMS, drive follow-ups, and transfer unresolved issues to MRB. You’ll audit processes for conformance to procedures/standard work, support continuous improvement aligned to GDP/GMP, and keep physical and electronic records organized for retention.

Essential Functions

  • Lead, coach, and train Quality Control personnel; provide feedback and input to performance appraisals.
  • Plan, prioritize, and direct inspection workloads; set expectations for throughput and quality.
  • Perform inspections on machined components and assemblies using visual/layout techniques and tools: microscopes, calipers, micrometers, and gages.
  • Create, complete, and compile inspection documentation to ensure material control, identification, and traceability.
  • Verify DHR alignment to DMR; uphold GDP on Routers, Inspection Plans, and DHRs through final lot release.
  • Document activities and maintain traceability within ERP and QMS; control records accurately.
  • Execute Incoming, In-Process, and Final Inspections; record nonconformities and escalate to MRB when needed.
  • Perform and supervise material sorts; train others on sorting and inspection standards.
  • Use advanced metrology (comparator, vision systems, basic CMM operation; contracers and automated techniques) and provide basic programming assistance for inspection/test methods.
  • Conduct First Piece and FAI inspections as assigned.
  • Evaluate process controls (SPC, Precontrol, Tool Life, Process Parameter) and train teams on requirements.
  • Perform process audits to confirm conformance to procedures and standard work.
  • Support continuous improvement and adhere to the TOMZ Quality Management System.
  • Follow safety and health practices including PPE requirements; support other Quality functions as needed; 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 5 years’ experience in a regulated manufacturing environment, or equivalent education and experience.

Qualifications

  • Fluent reading of blueprints, specifications, and procedures; strong attention to detail and on-time execution.
  • Knowledge of dimensional, visual, and mechanical inspection processes.
  • Competent with Microsoft Office; capable of independent and team-based work.
  • Strong verbal and written English communication; basic math proficiency.
  • Hands-on expertise with mechanical measurement tools: micrometers, calipers, dial indicators, height gages, pin gages, etc.
  • Experience in Class I, II, and/or III Medical Device manufacturing.
  • Background in regulated industries (Aerospace, Defense, Pharmaceutical, etc.).

Preferred Skills

  • Quality certifications (ASQ CQT, QCI, etc.).
  • Knowledge of and experience with GMP/ISO standards, including ISO 13485.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 50 pounds (team lift or mechanical assistance required over 50 pounds).
  • 20/20 vision (assisted or unassisted) for sorting raw and non-conforming materials; good dexterity for small to medium parts.
  • Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
  • Ability to sit or stand for prolonged periods; frequent computer and keyboard use.

Machines & Technologies You Will Use

  • Coordinate Measuring Machine (CMM) (Zeiss)
  • Measurement Gauges
  • Calipers and Micrometers

$27 - $32 an hour

Summary of Position Report directly to quality leadership and take ownership of day-to-day quality control within the department at TOMZ. We manufacture high-precision, metal machined and assembled co...

Big Lake, MN
Posted 4 days ago

Welcome to the exciting world of high-precision industrial manufacturing! At our company, we take pride in creating cutting-edge components for the medical device industry, using advanced metal machining techniques. If you are a detail-oriented professional skilled in CNC machinery and eager to make an impact, we might be looking for you!

Summary of Position

In this position, your primary responsibility will be the setup and manufacturing of components within the Swiss machining division. Maintaining ISO 13485 standards, you'll operate sophisticated equipment and perform meticulous visual and dimensional inspections to ensure exceptional quality in every piece produced.

Key Responsibilities

  • Skillfully operate and upkeep equipment like Citizen and Tsugami Lathes, Index multi-spindle lathes, and other complex machines.
  • Make necessary tool changes and adjustments for uninterrupted production flow.
  • Manage the setup of intricate components and fresh production orders.
  • Perform inspections utilizing various precision measuring tools to uphold high standards of manufacturing.
  • Conduct preventive maintenance to keep machinery in optimal condition.
  • Guide problem-solving initiatives on complex machine or process challenges.
  • Maintain thorough documentation for quality inspection and material traceability.
  • Foster a culture of continuous improvement and quality excellence.
  • Mentor and advise junior machinists to elevate their skills.
  • Ensure compliance with OSHA safety regulations and adhere to our Quality Management System.

Qualifications:

Qualifications

  • Extensive experience in regulated medical device manufacturing environments.
  • Solid background in GMP/ISO standards and quality control practices.
  • Equipped with a strong mechanical aptitude and understanding of blueprint reading.
  • Experience with troubleshooting and honing machine operations autonomously.
  • Proven communicator with excellent verbal and written English skills.

Physical Demands

  • Comfortable with physically-demanding tasks, including lifting and handling moderately heavy objects.
  • Prepared for occupational exposures, utilizing necessary PPE to ensure safety.

Become a vital part of our team and help shape the future of precision manufacturing!

$31 - $37 an hour

Welcome to the exciting world of high-precision industrial manufacturing! At our company, we take pride in creating cutting-edge components for the medical device industry, using advanced metal machin...

Summary of Position

Your day starts on the production floor at TOMZ, where precision matters. Reporting to the Department Manager, you guide complex medical device components through post-processing—from surface treatments to final markings—while upholding ISO 13485 documentation and uncompromising quality.

Essential Functions

  • Prepare parts and run them through metal finishing operations, including tumbling, blasting, heat treat, laser welding, laser marking, passivation, and anodize.
  • Conduct visual and dimensional inspections using tools such as a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, and Micro-Hite.
  • Complete, compile, and maintain documentation aligned with Quality Inspection standards and ISO 13485 requirements.
  • Maintain strict material control, identification, and traceability for both conforming and nonconforming parts throughout manufacturing.
  • Support GDP/GMP and Quality Best Practices with a mindset of continuous improvement.
  • Use ERP and QMS systems to document inspections and preserve traceability and process control.
  • Follow all occupational safety and health practices, including PPE requirements; uphold the TOMZ Quality Management System.
  • Perform other duties as assigned.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferable work experience (Manufacturing or Engineering discipline preferred).
  • 2–5 years of experience in a regulated manufacturing environment.
  • Strong verbal and written English communication skills are preferred.

Preferred Skills/Qualifications

  • Background in Class I, II, and/or III medical device manufacturing; or experience from a regulated field such as Aerospace, Defense, or Pharmaceutical.
  • Working knowledge of GMP/ISO standards and regulated manufacturing practices.
  • Hands-on experience with mechanical metal finishing equipment and processes, plus the ability to perform basic preventive maintenance with hand tools.
  • Ability to read and interpret blueprints, specifications, and procedures accurately.
  • Exceptional attention to detail, organization, and the ability to deliver work on time.
  • A self-starter who can work independently and collaboratively across R&D, Manufacturing, and QA with minimal supervision.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 50 lbs. Team lift or mechanical assist required above 50 lbs.
  • Comfort working around oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
  • Ability to sit or stand for prolonged periods.

$18 - $22 an hour

Summary of Position Your day starts on the production floor at TOMZ, where precision matters. Reporting to the Department Manager, you guide complex medical device components through post-processing...

If you excel at diagnosing complex machinery and guiding best-in-class maintenance practices, you’ll feel at home at TOMZ Corporation. In this Plant Equipment Controls & CNC Maintenance Lead role, you will support all Factory-assigned equipment, steer the maintenance group’s implementation and decision-making on best practices, and collaborate with cross-functional partners and Engineering to bolster production reliability.

Summary of Position

Medical devices change lives. You will help ensure the equipment that makes them runs safely, efficiently, and predictably in a modern, clean, and safe facility using state-of-the-art technology and continuous process improvement.

Essential Functions

  • Champion safety: follow all departmental safety measures and work instructions; model accountability for your safety and your teammates’.
  • Keep machines running: repair and maintain production equipment across electrical and mechanical domains.
  • Master the controls: work extensively with CNC and PLC-controlled machines; enter electrical control panels to troubleshoot issues.
  • Operate with certification: as an Arc Flash certified professional, perform work on “live” electrical control panels as required.
  • Diagnose with precision: apply precision measuring instruments; read and interpret diagrams, schematics, specifications, wiring diagrams, manuals, and blueprints.
  • Program and document: monitor, modify, and write ladder logic; create PLC programs and electrical drawings to support troubleshooting and modifications.
  • Build the infrastructure: install electrical, air, and data drops; design and implement electrical circuits and technologies to enable production.
  • Coordinate partners: engage outside contractors for repairs and verify completion accuracy.
  • Lead reliability: drive the selection and roll-out of maintenance best practices; collaborate with Plant Maintenance and cross-functional teams to improve uptime.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

Education

  • Associate degree in a technical discipline or equivalent experience.

Experience

  • 10+ years in the equipment maintenance field.

Qualifications

  • Demonstrated experience with CNC and PLC-controlled equipment, including routine maintenance and troubleshooting on CNC manufacturing equipment.
  • Fluency in MS Office.
  • Ability to prioritize effectively throughout the day; strong attention to detail and timeliness.
  • Hands-on self-starter; effective independently and within teams.
  • Strong English communication skills, written and verbal.

Pay Range: $30 - $43 an hour

If you excel at diagnosing complex machinery and guiding best-in-class maintenance practices, you’ll feel at home at TOMZ Corporation. In this Plant Equipment Controls & CNC Maintenance Lead rol...

Berlin, CT
Posted 4 days ago

Summary of Position

Supervises production team in assigned department(s). Improve safety, quality, delivery, productivity, and cost. Increase team skills and capabilities. Continuously improves associate satisfaction while increasing efficiency.

Essential Functions

  • Safe operation of all production processes. Identifies needed improvements and leads the project's implementation. Continually monitors the area and solicits feedback from associates. Enforce all safety rules and regulations.
  • Is the key coordinator/communicator for at least one safety training program for the entire organization.
  • Supervises team members. Ensures effective employee relations. Resolves issues through problem resolution. Confers with management to resolve complex associate matters.
  • Interviews, selects, orients, trains, conducts performance appraisals, performance development, schedules, and approves hours.
  • Provides leadership for associate relations through effective communication, coaching, training, and development.
  • Executes operational plan to enhance profitability, productivity, and efficiency throughout assigned production department(s).
  • Implements Lean Manufacturing techniques to improve quality, cost, on-time delivery, safety, customer satisfaction, and associate satisfaction.
  • Maintains production plan.
  • Ensures compliance with the organization's standards for cost control, waste reduction, quality, safety, and on-time delivery.
  • Provides training and support to the team, sets goals and objectives.
  • Measures team performance for safety, quality, delivery, and cost. Work with teams to continually improve these measures.
  • Monitors the budget.
  • Arranges for equipment, materials, and supplies to be available for work assignments.
  • Approves setups and assigns operators. Troubleshoot bottleneck operations to identify the cause and notify the appropriate support team for assistance.
  • Checks work methods and operations to make recommendations for improving quality and implement systems to report and reduce scrap and cost.
  • Oversees the use of SPC.
  • Identifies opportunities aimed at continuous improvement of the quality of products and processes. Leads project team during identification through implementation and evaluation.
  • Confers with others to coordinate operations and activities across all shifts.
  • Adhere to the TOMZ Quality Management System.
  • Perform other duties as assigned.

Qualifications:

Education

  • Bachelor’s degree or 4-year equivalent directly transferable industry work experience.

Experience

  • Minimum of 5 years of manufacturing or engineering experience in a supervisory role.

Qualifications

  • Ability to maintain a safe work environment.
  • Experience in the setup and operation of manufacturing equipment.
  • Knowledge of production and processing and other techniques for maximizing the effective manufacture of our products.
  • Broad experience with precision components and assembly.
  • Kaizen and Lean Manufacturing techniques.
  • High attention to detail and ability to think ahead.
  • Knowledge of production cycle.
  • Demonstrated ability to lead people and get results through others.
  • Solid analytical skills
  • Excellent interpersonal and communication skills to work with associates, customers and vendors.
  • Excellent project and program management skills.
  • Ability to multitask in a fast-paced environment and manage multiple priorities.
  • Ability to solve practical problems and deal with a variety of changing situations.
  • Quality orientation
  • Knowledge of human resources and safety includes coaching, performance management, OSHA and related safety standards.
  • Knowledge of mathematics to include geometry and statistics.
  • Ability to think critically and use judgment to identify strengths and weaknesses of solutions to problems presented in production.
  • Computer skills include word processing, spreadsheets, and databases.
  • A self-starter capable of working independently and as part of a team.

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 or stand for prolonged periods.
  • Perform keyboard entries with frequent operation of a computer.
  • Exposure to oil, grease, dust, metal particles, sparks, sharp-edged materials. Some exposures may require the use of personal protective equipment or engineering controls.

Machines & technologies you'll use:

  • CNC Mill (3-4 axis VMC)
  • CNC Lathe (2-4 axis)
  • CNC Swiss Lathe (Citizen, Tsugami, Index)
  • CNC Mill (5+ axis VMC)
  • CNC Lathe (5+ axis)

Summary of Position Supervises production team in assigned department(s). Improve safety, quality, delivery, productivity, and cost. Increase team skills and capabilities. Continuously improves associ...

At TOMZ, we pride ourselves on crafting impeccable medical device components through precision metal machining. If you're a meticulous professional with a knack for maintaining standards and guiding teams, your expertise could find a perfect home here.

Summary of Position

Reporting directly to our quality leadership, your primary mission is to champion our quality control processes. Expect to immerse yourself in the dynamics of ISO 13485 standards, ensuring each component produced meets the highest benchmarks of excellence.

Core Responsibilities

  • Head up and mentor a team of skilled Quality Control personnel. Provide strategic direction and oversight to align workloads with organizational targets.
  • Masterfully inspect machined components using an assortment of tools, including microscopes, calipers, and micrometers.
  • Generate and manage comprehensive documentation that adheres to Quality Inspection standards.
  • Ensure that Device History Records reflect the utmost conformity with the Device Master Record.
  • Leverage ERP and QMS systems to reinforce record integrity and traceability.
  • Participate in and promote continuous improvement initiatives aligned with best practices and regulatory standards.
  • Spearhead critical inspections — from Incoming to Final — and manage nonconformities effectively.
  • Adapt seamlessly to varied quality requirements across different production lines while supporting department objectives.
  • Conduct and oversee nuanced inspections using advanced technologies like comparators and CMM systems.

Qualifications:

Education/Experience

  • Education: A high school diploma or GED, with a preference for manufacturing or engineering disciplines.
  • Experience: 5+ years in a regulated manufacturing environment, with exposure to Class I, II, or III Medical Device production.
  • Desirable Credentials: Holding quality certification(s) such as ASQ CQT or QCI; familiar with GMP/ISO standards.

Preferred Skills/Qualifications

  • An analytical thinker with proficiency in reading technical blueprints and specifications.
  • An advocate for accuracy, showcasing attention to detail in all tasks.
  • Adept in software tools like Microsoft Office and comfortable operating independently or in collaboration with others.
  • Experienced with mechanical measurement instruments, such as micrometers and calipers, underpinned by knowledge of mechanical inspection processes.

Physical Demands

  • Capability for handling up to 50 pounds, with assistance for heavier items.
  • 20/20 vision required for precision sorting and inspections.
  • Regular exposure to elements like oil, grease, and cleaning solvents.


At TOMZ, we pride ourselves on crafting impeccable medical device components through precision metal machining. If you’re a meticulous professional with a knack for maintaining standards and gui...

Full Time
Big Lake, MN
Posted 4 days ago

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. Creating 1st pc and in- process inspection plans, process validations, equipment specification for production line-up and fixturing design.

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.
  • Create 1st pcs and in-process inspection plans.
  • Design fixtures for post processing operations.

Qualifications:

Education

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

Experience

  • Minimum of 5 years’ experience of programming in a medical device manufacturing environment or similar

Preferred Skills/Qualifications

  • Strong knowledge of NC Code, Tooling, and Manufacturing Process.
  • Knowledge of CAD/CAM software (SolidWorks and Esprit preferred)
  • Blueprint reading and knowledge of Geometric Dimensioning and Tolerancing (GD&T)
  • Effective communication to all levels of internal and external customers
  • Ability to apply logic and reasoning to solve complex problems.

Pay Range: $69,000 - $125,000 a year

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...

Full Time
Berlin, CT
Posted 4 days ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Maintenance Machine Specialist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

The purpose of the Senior Maintenance Machine Specialist is to provide production equipment support for all equipment allocated to the Factory as well as to assist engineering with production-related projects. Routinely works with Plant Maintenance to coordinate jobs and projects. The Senior Maintenance Machine Specialist will take the lead in the implementation and the decision-making process on best practices for the maintenance group. The position is also responsible for creating solutions and providing technical support to enhance production reliability through concerted efforts with cross functional teams.

Essential Functions

  • Prepare and process components through various metal finishing operations.
    • Tumbling
    • Blasting
    • Heat Treat
    • Laser Welding
    • Laser Marking
    • Passivation
    • Anodize
  • Perform visual and basic dimensional inspections on completed components, as required using micrometers, calipers, microscope, etc.
  • Completes and compiles necessary documentation related to Quality Inspection standards.
  • Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
  • Support Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
  • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
  • Other duties and responsibilities are assigned.

Qualifications:

Education

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

Experience

  • Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Qualifications

  • Ability to use basic hand-held tools to support preventive maintenance activities.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.
  • Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
  • Must have good organizational skills.

Preferred Skills

  • Ability to effectively read and understand blueprints, specifications, and procedures.
  • Knowledge of and experience with GMP/ISO standards.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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 Senior Maintenance Machine Specialist to join our organization. TOMZ offers c...

Full Time
Fishers, IN
Posted 3 weeks ago

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

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • 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.
  • Other duties and responsibilities as assigned.

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).

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...

Full Time
Big Lake, MN
Posted 1 month 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.

$19 - $22 an hour

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...

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

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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

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.