Rewarding Careers

SUMMARY OF DUTIES: To setup and operate archwire and coiler machines and to be responsible for the quality of the products your assigned machine produces.

ESSENTIAL DUTIES: Reads job specifications to determine machine adjustments and material requirements.

Sets stops, guides & cams to specified length as indicated by scale, rule, or template.

Observes machine operation to detect workpiece defects or machine malfunction.

Measures workpiece dimensions to determine accuracy of machine operation per WI.

Performs minor machine maintenance such as oiling machines, dies, or workpieces.

EDUCATION LEVEL: High school diploma or general education degree (GED)

EXPERIENCE: one to three months related experience

SUMMARY OF DUTIES: Sets up and operates Fourslide to trim, punch, shape, notch and crimp metal.

ESSENTIAL DUTIES: Selects cams, forming tools, and dies according to setup sheets.

Aligns and bolts specified cams to shaft, forming tools to tool blocks and die sets to machine rams when applicable.

Threads stock through stock straighteners.

Turns flywheel by hand to produce sample part and compares sample with specifications.

Synchronizes action of slides to feed, cut-off and form part. Readjusts machine to achieve specified product dimensions.

Starts machine and observes operation periodically gauging parts for conformance to specifications.

Removes, replaces, and labels trays of finished products.

Inspection of product using measuring equipment and SPC data.

EDUCATION LEVEL: High School Diploma or equivalent.

EXPERIENCE: Four to ten years related experience and/or training.

SUMMARY OF DUTIES: Build, maintain, trouble shoot and improve fourslide and/or power press tooling to produce parts of high quality. Build or repair other tooling, machine parts, gages and fixtures as assigned by supervisor. Wire EDM knowledge helpful.

ESSENTIAL DUTIES: Square up blocks of tool steel.
Heat treat tool steel.
Verifies dimensions, alignments and clearance.
Assemble components to completion of new tooling.
Set new tooling in 4 Slide and or Power Press and troubleshoot to produce parts to print.
Troubleshoot & repairs existing tooling as needed.
Examine previously used dies, tools, jigs and fixtures. Recommend design modifications.
Convert part files to dxf files for HAAS & WEDM machines.
Operate all tool room equipment to produce tooling as required.

EDUCATION LEVEL: High Schcool Diploma or equivalent.

EXPERIENCE: Four to ten years related experience.

SUMMARY OF DUTIES: Responsible for day to day maintenance, cleaning and assisting facility manager with daily maintenance, activities, alteration of equipment, machinery, buildings and other facilities.

ESSENTIAL DUTIES: The essential functions include, but are not limited to the following:
• Analyzes and fixes maintenance problems.
• Troubleshoots and repairs electrical issues.
• Performs minor machine maintenance and adjustments such as oiling machines, dies, or workpieces.
• Ensures operation of equipment by calling for repairs; evaluating new equipment and techniques.
• Inspects plant and evaluates use of space and facilities.
• Analyzes firm's HVAC systems, computer network wiring, lighting, and other factors.
• Ensures that the facilities building & grounds are maintained, including the cleanliness attached to all areas, both in & outdoors.
• Meets company policies, safety rules and regulations.
• Meets with hourly employees to help resolve any maintenance issues and assist with their tasks.
• Maintains a clean and safe work area to decrease potential safety hazards.
• Maintains lawn and upkeep of property.
• Performs snow removal and sanding of parking lot, walk ways and staircases.
• Performs other duties as needed.

EDUCATION LEVEL: • High school diploma or equivalent required.

EXPERIENCE: • Two years related experience and/or training; or equivalent combination of education and experience.
• Knowledge of various crafts/ trades.
• Forklift certified.

SUMMARY OF DUTIES: Assemble and package medical guidewires.

ESSENTIAL DUTIES: Follow procedures specific to each operation.

Thread Ribbon. Etch. Inspect. Re-work. Clean. Roll & Buff. J. Pack.

All functions are done as part of a cell environment, where it is important to the entire group reaching a certain quota.

EDUCATION LEVEL: High school diploma or general education degree (GED)

EXPERIENCE: No experience necessary. Must have good finger dexterity.

SUMMARY OF DUTIES: Manufacture Niti Orthodontic Archwires

ESSENTIAL DUTIES: Follow procedures specific to each operation.

Archwire forming, cleaning, inspection, & package

All functions are done as part of a cell environment where it is important to the entire group reaching a certain quota.

EDUCATION LEVEL: High school diploma or general education degree (GED)

EXPERIENCE: No experience necessary. Must have good finger dexterity,

SUMMARY OF DUTIES: Tracks and reports status of production jobs. Issues and requests materials for winding and medical components. Maintains scheduling board for medical. Ensures jobs moving through the department are based on priority.

ESSENTIAL DUTIES: The essential functions include, but are not limited to the following:
• Maintains production work center line up reports.
• Planning and scheduling medical components.
• Managing the webcam board.
• Monitors stock levels and creates jobs for consignment.
• Work with Purchasing Director to ensure that material is on order and is delivered when needed for the production run.
• Work closely with the Sales team in providing job status and answers to expedite requests.
• Identify when jobs are running late.
• Updates production status database.
• Track and report daily production quantities.
• Coodinates issuing raw material to production floor.
• Works closely with Medical Supervisor, PI, and Winding Supervisor.
• Adhere stringently to all safety guidelines by keeping work area clean and wearing protective clothing.
• Performing other duties as assigned.

EDUCATION LEVEL: • High School Diploma or GED

EXPERIENCE: • 2 years related experience and/or training; or equivalent combination of training and experience.

SUMMARY OF DUTIES: Inspect / Package Orthodontic Archwires.

ESSENTIAL DUTIES: Inspect archwire to customer specifications
Package archwires per customer specifications

EDUCATION LEVEL:

EXPERIENCE: No experience necessary. Must have good finger dexterity.

SUMMARY OF DUTIES: To develop, implement, coordinate, and ensure the organizations compliance to the scope of the quality management system. To maintain the scope of the quality management system in alignment with the strategic direction of the organization, as instructed, for the devices and products produced, and customers and markets served. To ensure that necessary systems have been established to ensure devices and products are manufactured in compliance with customer, quality management system, regulatory and/or statutory requirements.

ESSENTIAL DUTIES: • Ensures compliance to ISO9001, EN ISO13485, EU MDD/MDR, MHLW (Japan) Ministerial Ordinance No. 169, and FDA/cGMP Quality Management System requirements in multiple facilities.
• Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
• Cooperates with top management personnel in formulating and establishing company policies, operating procedures, and goals.
• Develops initial and subsequent changes of quality management system to delineate areas of responsibility, personnel requirements, and operational procedures.
• Ensures the timely reporting of the effectiveness of the quality management system, such as weekly, monthly, quarterly, and annual reports, and as required under the scope of the quality management system.
• Ensures the timely reporting of device quality issues by communicating closely and reporting information to the Director, Quality Assurance and Corporate Regulatory Affairs, as required under the scope of the quality management system.
• Helps drive and support the ISO 9001/13485 Internal Audit program.
• Provides leadership and supervision to the Quality Assurance and Quality Control functions which report to the position, to ensure that the goals and objectives of the organization are achieved.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Collaborates with external providers (vendors) to ensure their compliance to quality management system requirements and help to address quality and/or other issues.
• Helps support compliance activities concerning new devices and/or products to ensure their compliance with customer and/or regulatory requirements.
• Confers with the applicable departments for manufactured devices and/or products to rectify any complaints, non-conformances and/or other issues.
• Oversees process, product, and equipment validations for the New Britain, CT facility.
• Promptly discontinues further processing and/or delivery of non-conforming devices and/or products until the discrepancy or non-conforming condition has been corrected.
• Reviews technical publications, articles, and abstracts to stay abreast of compulsory standards and regulatory requirements as they relate to the scope of the quality management system and products manufactured in the New Britain, CT facility.
• Investigates customer complaints, perform root cause analysis, identify corrective and preventive action, and prepare reports for customer submission, in a prompt manner.
• Designs, implements, and maintains quality management system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements.
• Ensures that the processes required for the quality management system are established, implemented, and are being effectively maintained.
• Ensures that the policies, procedures, and work instructions of the quality management system are communicated to the organization.
• Reports to management on the performance of the quality management system and the need for any actions and/or improvements to maintain its effectiveness.
• Promotes awareness of customer and/or quality management system requirements throughout the organization.
• Serves as the company’s liaison to external parties on matters relating to the quality management system in the New Britain, CT facility.
• Performing other duties as assigned.

EDUCATION LEVEL: • Bachelor’s degree from four year college or university • At least ten yrs of related experience

EXPERIENCE: • Preferred PhD in field relevant to medical devices covered under the scope of MDD/MDR

SUMMARY OF DUTIES: • Manages and prioritize daily Quality Control inspection activities based on production needs.
• Directs Quality Control Inspectors in daily tasks and provide training to inspectors where necessary.
• Works closely and cooperatively with the Production Supervisor/Operators to investigate and resolve product quality issues.
• Performs product quality inspections/testing at various stages of production, such as Component Receiving Inspection, In-Process and Final Inspection and record data onto quality forms.
• Reviews Device History Record (DHR) documentation and ensure compliance to company Quality Management System (QMS), FDA cGMP, ISO 13485 and customer requirements.
• Prepares Final Inspection Reports and Certificates of Compliance using Microsoft Computer Applications as well as custom company software.
• Collaborates with other departments, such as Production, Sales, and Engineering, to prevent/resolve quality issues.
• Communicates significant quality issues to the QA Management team.
• Assists with internal audits.
• Supports Quality Team in customer and FDA/ISO audits.
• Performs complaint investigations, root cause analysis and corrective actions.
• Other duties as assigned.

ESSENTIAL DUTIES:

EDUCATION LEVEL: • High School Diploma/ (GED) • Two (2) years Quality Control & Supervisory Experience

EXPERIENCE: • Medical Device Manufacturing Experience Preferred
• Knowledge of FDA cGMP and ISO 13485 Preferred
• Clean Room Environment Experience Preferred

SUMMARY OF DUTIES: Tests and inspects products at various stages of production process to determine and maintain quality and reliability of products by performing the following duties.

ESSENTIAL DUTIES: • Selects products for tests at specified stages in the production process and tests products for a variety of qualities such as dimensions, performance, and mechanical characteristics.
• Records test data, applying statistical quality control procedures where applicable.
• Sets up and performs destructive and non destructive tests on materials, parts, or products to measure performance or material characteristics.
• Prepares graphs or charts of data or enters data into computer for analysis.
• Discontinue further processing and delivery of non conforming products until the discrepancy or non-conforming condition has been corrected.
• Initiates actions to prevent the occurrence of product non-conformity.
• Performs other related duties as assigned.

EDUCATION LEVEL: High School Diploma or GED

EXPERIENCE: • Experience with quality control techniques
• Experience with measuring devices such as meters, gauges, computers, calipers, and other measuring instruments
• One to two years’ quality experience

SUMMARY OF DUTIES: Setting up and operating CNC and mechanical wireforming and coiling equipment following the requirements defined in the job traveler and specification documents. Responsible for daily maintenance activities on the machines, and for the quality of product being produced.

ESSENTIAL DUTIES: • Reads job travelers and specifications to determine machine adjustments and material requirements.
• Sets up the machines to meet and/or exceed productivity output and quality requirements
• Works with production planner to ensure that raw materials are available at the expected time of machine set-up
• Measures part to specifications to determine accuracy of machine operation prior to submission to Quality Control.
• Observes machine operation to detect workpiece defects or machine malfunction.
• Works cooperatively with QC Technicians during part production to ensure product meets customer specifications. Makes adjustments as required to meet define quality expectations
• Performs daily machine maintenance and reports any machine issues encountered during maintenance or production to the department supervisor and Maintenance department.

EDUCATION LEVEL: High School Diploma/GED

EXPERIENCE: one-three years experience.
Trained in S.P.C and data entry.

SUMMARY OF DUTIES: Assists supervisor and Lead Person in manufacturing guidewires.

ESSENTIAL DUTIES: The essential functions include, but are not limited to the following:
• Dresses and services all grinders.
• Performs machine PM.
• Aids supervisor and Lead Person in machine set up and cell changeovers as required.
• Aids supervisor and Lead Person in QC.
• Aids supervsior in inventory control.
• Works in cell as required.
• Refers all personnel issues to supevisor.
• Leaves detailed and understandable notes as to the problem and status of jobs when necessary.
• Refers extensive machine repairs to maintenance personnel.
• Performing other duties as assigned.

EDUCATION LEVEL: • High school diploma or equivalent required

EXPERIENCE: • Reading Micrometers, Rules & AMC Blue Prints
• Related experience and/or training; or equivalent combination of education and experience.

SUMMARY OF DUTIES: Build, maintain, trouble shoot and improve fourslide and/or power press tooling to produce parts of high quality. Build or repair other tooling, machine parts, gauges and fixtures as assigned by supervisor.

ESSENTIAL DUTIES: The essential functions include, but are not limited to the following:
• Use sketches, blueprints, specifications and models to plan operations for the fabrication of dies, tools and assemblies, ensuring safety and maximum efficiency
• Verify dimensions of finished parts to ensure they conform to specifications using measurement equipment including but not limited to dial indicators, gauge blocks, calipers and micrometers
• Utilize hand and machine tools to assemble parts of tools and dies and to repair and modify gauges, jigs and dies
• Design templates and jigs to be used as work aids for convenient fabrication of products and parts
• Diagnose and troubleshoot problems and perform repairs on tools, manually operated dies and progressive dies
• Interface with external and internal customers, handle supplier and customer concerns, and work with team members to solve problems during the production process
• Finish workpieces using the appropriate hand tools to ensure products are smooth and that they fit together properly
• Select the appropriate metals and materials to be used based on properties, ensuring they meet project specifications
• Set new tooling in fourslide and or power press and troubleshoot to produce parts to print.
• Performing other duties as assigned.

EDUCATION LEVEL: • High school diploma or equivalent required

EXPERIENCE: • Related experience and/or training; or equivalent combination of education and experience.

SUMMARY OF DUTIES: Assists in product counts, packaging and preparation for shipment. Drives parts to and from processing companies, as well as employees to shows, airports or events as requested.

ESSENTIAL DUTIES: The essential functions include, but are not limited to the following:

• Signs and maintains shipping documents
• Wraps bags or boxes items for shipment, inventory or processing
• Affixes labels or documentation
• Retrieves or replaces inventory as needed
• Drives company truck to deliver and pick up material or transport employees
• Counts, packages and inventories finished goods
• Performing other duties as assigned

EDUCATION LEVEL: High School Diploma or GED and valid driver's license

EXPERIENCE: • 1 - 2 years experience in similar field
• Valid DOT Medical Card to drive company box truck preferred