Join Us on Our Mission to Improve Patients' Lives.

Explore a day in your new role: Imagine joining a team that innovates and moves the medical device industry forward with expertise in metal machining and quality assurance. As part of this team, your focus is the Swiss machining department where your attention to detail and machine setup skills ensure the manufacturing of top-tier components.

Summary of Position

Operating hands-on with our sophisticated technology, you’ll ensure precision in every product. Your tasks include setting up equipment, conducting thorough inspections, and adhering to our world-class ISO 13485 standards. Take charge in running complex machinery and shape the future of our innovative products.

Essential Functions

• Operate and maintain CNC machinery, including Citizen and Tsugami Lathes, while managing tool changes and production efficiency.
• Set up for continuous operation by configuring new and existing production orders.
• Perform and log inspections, actively engaging with precision measurement tools.
• Engage in equipment maintenance and troubleshoot complex machine issues.
• Document and uphold quality standards in every aspect of the production cycle.
• Collaborate effectively across various departments to push operational excellence.
• Mentor junior team members and foster a learning environment.
• Commit to safety, employing PPE and following guidelines to ensure a safe workplace.

Qualifications

• Demonstrated experience in a tightly regulated manufacturing setting.
• A flare for understanding and applying GMP/ISO criteria in a fast-paced environment.
• Skilled in utilizing precision instruments and interpreting technical blueprints.
• Ability to independently manage equipment care and mechanical troubleshooting.
• Superior communication capabilities, essential for team interaction and documentation.

Physical Demands

• Adaptable to physical requirements which include lifting and positioning tools and materials.
• Comply with health standards in environments exposed to industrial materials.

At TOMZ, we craft precision components for life-changing Medical Devices using advanced metal machining, finishing, assembly, and anodizing. Step into our Swiss machining department and take ownership of complex setups, tight-tolerance production, and inspection excellence in a regulated environment.

A Day in This Role

You arrive to the Swiss cell, review your work orders, and begin prepping a Citizen or Tsugami lathe. You load tools, dial in offsets, and bring a legacy job back to life with steady, repeatable performance. Between cycles, you verify critical features with microscopes, micrometers, calipers, pin and thread gauges, comparators, Micro-Hite, CMM, and vision systems. When the schedule shifts, you pivot to an Index multi-spindle lathe or move to 3-, 4-, or 5-axis production equipment—including Robo Drills, mill-turn platforms, and horizontal/vertical mills—to keep delivery promises on track.

Throughout the day, you document to ISO 13485 standards, maintain material identification and traceability for both conforming and nonconforming parts, and record results in our ERP and QMS systems. You troubleshoot a stubborn surface finish, swap a tool, adjust wear offsets, and lead a quick root-cause session. You perform preventive maintenance, mentor junior machinists, and keep safety and PPE front-and-center. You collaborate with Manufacturing, R&D, and QA to refine processes—always with GDP/GMP best practices in mind.

Essential Functions

• Set up and operate Citizen and Tsugami Swiss lathes, Index multi-spindle lathes, and 3–4–5 axis production equipment (Robo Drills, mill-turn, horizontal/vertical mills).
• Perform tool changes and offsets to drive efficient, stable production with minimal support.
• Run complex legacy components and launch new production orders.
• Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro-Hite, CMM, and vision systems.
• Complete ISO 13485-compliant documentation and quality records; utilize ERP/QMS for traceability and inspection control.
• Ensure material control, identification, and traceability for conforming and nonconforming product.
• Lead problem-solving for challenging machine/process issues and perform scheduled preventive maintenance.
• Support Quality Best Practices and continuous improvement in GDP/GMP; contribute to a culture of improvement, quality, and on-time delivery.
• Mentor and train lower-level machinists; adhere to the TOMZ Quality Management System and all safety/PPE requirements.

Qualifications:

Education/Experience

• Certification from a technical school program or equivalent directly transferable experience in manufacturing/engineering accepted.
• Technical school certification strongly preferred.
• 3–7 years in regulated manufacturing; experience with Class I/II/III medical devices using calibrated equipment and hazardous materials.

Preferred Skills/Qualifications

• Background in aerospace, defense, or automotive manufacturing is valuable.
• Working knowledge of GMP/ISO and ISO 13485 requirements; strong understanding of machine operation, care, and inspection processes.
• Proficient in blueprint/specification interpretation and procedures; intermediate GD&T.
• Hands-on ability with hand tools for PM, repairs, and tool changes.
• Organized, detail-focused, and skilled at identifying nonconformances.
• Self-starter who can work independently and on cross-functional teams with R&D, Manufacturing, and QA.
• Strong verbal and written English communication skills.

Physical Demands

• Ability to sit or stand for prolonged periods.
• PPE such as dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.

Summary of Position

Imagine waking up each day to ensure that every piece produced aligns with the gold standard of quality. As a Quality Systems Inspector at TOMZ, you'll be at the heart of producing stellar medical device components.

Essential Functions

• Lead the Charge: Guide a collaborative team, aiming for precision and effectiveness in maintaining our ISO 13485 standards.
• Inspect Meticulously: Use tools like calipers and micrometers to ensure machined components meet rigorous criteria.
• Document Mastery: Develop comprehensive documentation that traces the lifecycle of each component, ensuring transparency and accountability.
• Advocate Continuous Improvement: Foster processes that enhance our quality standards while embracing production shifts and evolving industry practices.

Qualifications:

Education/Experience

• A minimum of 5 years’ experience in the regulated manufacturing sector.
• A background in mechanical measurement, ensuring the integrity of our production processes.
• Preferred education includes a high school diploma or equivalent, with additional credentials in manufacturing.

Preferred Skills/Qualifications

• Strong analytical skillset with an ability to interpret detailed blueprints and specifications.
• An eye for detail that ensures all tasks are performed with utmost precision.
• Knowledgeable in mechanical inspections and adept at utilizing an array of inspection tools.
• Ability to thrive both independently and in dynamic team settings.

Physical Demands

• Comfortable managing up to 50 pounds independently.
• Possesses keen vision for detailed inspection work.
• Adaptable to environments inclusive of oils, solvents, and noise, abiding by safety protocols.

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

Reporting to 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 parts and run them through various metal finishing operations.
  • Tumbling
  • Blasting
  • Heat Treat
  • Laser Welding
  • Laser Marking
  • Passivation
  • Anodize
• Perform visual and dimensional inspections on manufactured components, as required using a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, Micro-Hite, 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.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education/Experience

• 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.

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.
• Must demonstrate good organizational skills.
• Strong verbal and written English communication skills are preferred.

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.
• 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.
• Ability to sit or stand for prolonged periods.

$18 - $22 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 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

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

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

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.

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).