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: 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. To serve as the company ISO/quality management system representative.

ESSENTIAL DUTIES: • Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
• To 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 to regulatory authorities, as required under the scope of the quality management system.
• Confers with top management to formulate the fiscal budget for the quality management system.
• To manage the Quality Assurance and Quality Control functions which report to the position, to ensure that the goals and objectives of the organization are achieved, and ensuring compliance to the scope of the quality management system.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• To visit and/or confer with representatives of external providers (vendors) to ensure their compliance to quality management system requirements. To address and/or work with external providers to address quality and/or other issues.
• Confers with the applicable departments concerning new devices and/or products to ensure their compliance with customer and/or regulatory requirements.
• To confer with the applicable departments for manufactured devices and/or products to rectify any complaints, non-conformances and/or other issues.
• To promptly discontinue 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.
• Investigate 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.
• To enhance customer satisfaction through the effective application of the quality management system for continual improvement and/or its effectiveness. And the assurance of conformity to customer and/or 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.
• Reporting 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.
• Performing other duties as assigned.

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

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

SUMMARY OF DUTIES: Operates one or more fourslide / presses to automatically punch, cut and form metal strips and wire to fabricate parts such as flat springs, brackets and clips by performing the following duties:

ESSENTIAL DUTIES: Verifies that proper raw material along with associated paperwork is correct for each job
Minor adjustments to machine to achieve specific product dimensions.
Restock and start up machine verifying parts are to specifications.
Identifies product by use of job travelers and routes product to next operation.
Determine and report malfunctions to appropriate parties.
Ensure compliance with with regulatory and company policies and procedures.
Inspection of product using measuring equipment and SPC data.

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

EXPERIENCE: SPC Certified
One to three months related experience and/or training; or equivalent combination of education and 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: The Manufacturing Engineer plans, directs and coordinates manufacturing processes for a production facility. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines the parts, equipment, and tools needed in order to achieve manufacturing goals according to product specifications.

ESSENTIAL DUTIES: • Evaluates and plans methods for manufacturing of proposed new parts in a timely fashion (quotations).
• Enters new parts and sample jobs into Epicor production system and schedules new part meetings for planning of production within two days of receipt in the department*
• Processes Engineering Change Requests within two days of receipt in the department and track ECN’s through the process until given to QA*
• Develops, evaluates and improves manufacturing methods for cost savings or increased quality (Lean initiatives)
• Confers with customers concerning product design to ensure efficient and cost effective production methods
• Confers with vendors to determine product specifications and evaluates products according to specifications and quality standards
• Confers with management, sales and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes
• Supports quality and production by providing method masters, inspection overlays, product drawings and specifications
• Develops specifications for new products and materials as needed
• Introduces new products following the design and development process
• Manage projects as they are assigned including setting timeline and milestones to be met
• Performing other duties as assigned

EDUCATION LEVEL: •Associate or Bachelor of Science in Mechanical or Manufacturing Engineering or Engineering Tech.

EXPERIENCE: • 5 years minimum experience
• Excellent analytical skills with the ability to assess problems or issues with manufacturing
• Strong knowledge of manufacturing equipment
• Excellent organizational skills and attention to detail
• Experience with SolidWorks (preferred) or other CAD software
• Proficient in Microsoft Office Suite or similar software
• Excellent verbal and written communication skills
• Excellent time management skills with proven ability to meet deadlines

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: 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: Ensure conformity of Medical Devices and compliance with all customer requirements. quality management system standards and applicable statutory and regulatory requirements.

Design & Process validations (IQ,OQ,PQ).

ESSENTIAL DUTIES: Perform quality reviews of product specification documentation for compliance with stated requirements.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Reviews all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.
Develops new approaches to solve problems identified during quality assurance activities.
Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
Prepares and presents technical and program information to the management team.
Directs technical and administrative workers engaged in quality assurance activities.
Maintains a working knowledge of government and industry quality assurance codes and standards.
Plays an active role on quality management teams within the organization.
Designs and implements quality assurance training programs to key personnel in conjunction with managers.
Perform internal audits within the company's facilities.
Visit, confer and/or assist representatives of vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
Confer with the applicable departments about quality assurance of new and/or existing products to ensure product quality. Confer with the applicable departments for manufactured products on the market to rectify problems.
Identify, create, implement and maintain quality assurance system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements.
Investigate customer complaints, perform root cause analysis, identify corrective action, and prepare reports for customer submission. Includes verbal, written and direct customer contact with regards to complaint resolution.
Investigate internal non-conformances, perform root cause analysis, identify corrective and preventative action, and prepare reports.
To discontinue further processing and delivery of non-conforming product until the discrepancy or non-conforming condition has been corrected.
To initiate actions to prevent the occurrence of product non-conformity.

EDUCATION LEVEL: Bachelor's degree (B. A.) in a technical field, preferably engineering or science and/or an Associat

EXPERIENCE:

SUMMARY OF DUTIES: This position will develop, implement, coordinate, maintain, and ensure the organization’s compliance to the scope of the quality management system (EN ISO 13485, MDD 93/42/EEC, MDR 2017/745, KFDA).

ESSENTIAL DUTIES: • Ensures the timely reporting of device quality issues to regulatory authorities, as required under the scope of the quality management system.
• Confers with the applicable departments concerning new devices and/or products to ensure their compliance with customer and/or regulatory requirements.
• To confer with the applicable departments for manufactured devices and/or products to rectify any complaints, non-conformances and/or other issues.
• To promptly discontinue 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.
• Investigate 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.

• To enhance customer satisfaction through the effective application of the quality management system for continual improvement and/or its effectiveness. And the assurance of conformity to customer and/or applicable statutory and regulatory requirements.
• Ensures that the processes required for the quality management system are established, implemented, and are being effectively maintained.
• Access the business’ future ventures to identify possible compliance risks.
• Review the work of colleagues when necessary to identify compliance issues and provide advice or training.
• Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
• Prepare reports for senior management and external regulatory bodies as appropriate.
• Performing other duties as assigned.

EDUCATION LEVEL: Bachelor’s degree from a four year college/university or at least ten years of related experience

EXPERIENCE: Preferred - PhD in field relevant to medical devices covered under the scope of FDA, MDD, MDR

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: The main responsibilities of this position include but are not limited to:
• Planning, scheduling, and managing the manufacturing of customer orders for timely shipment

• Leading a group of manufacturing personnel in the production and assembly of medical devices. Providing individual feedback on manufacturing personnel performance accompanied by training recommendations.

• Diagnosing manufacturing problems and recommending corrective and preventive actions
• Assisting with set-up, troubleshooting and preventive maintenance activities on equipment.
• Understanding, following, and assisting in the creation of manufacturing procedures and work instructions

• Work closely with the sales and purchasing departments to ensure that customer needs and production requirements are met

• Active participation in Production, Quality, and Work Environment Continuous Improvement programs. Maintaining a safe and clean working environment in compliance with facility guidelines and procedures.

• Organizing work and storage areas for efficient workflow and cleanliness of the facility.

• Maintaining complete and accurate records of work: in-process, component inventory, and related documentation as appropriate.

• Accepting accountability for product quality and safety.

ESSENTIAL DUTIES:

EDUCATION LEVEL:

EXPERIENCE: Position Qualifications:
• Associates, Bachelor’s, or Technical Degree in a manufacturing related discipline with 2 - 4 years of related experience,
OR,
• Minimum two (2) years supervisory experience of production personnel, and Minimum four (4) years of experience working in a manufacturing environment.
Requirements:
• Excellent attention to detail and dexterity needed to handle very small parts.
• Technical aptitude to assist in the set-up, troubleshooting and maintenance of manufacturing equipment
• Solid Excel skills; ability to read drawings and schematics.
• Patience and satisfaction in completing work with a high level of quality.
• Demonstrated ability to work accurately, follow instructions/schedules/timelines. Must be flexible and able to adapt to changes in priorities.
• Good written, prioritization and organizational skills.
• Ability to lead and collaborate with different levels of people and positions internally and externally to the organization.
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Must be able to work independently with minimal guidance required, with good time management, planning, organization, and decision-making skills.
• Intermediate mathematical skill level.
• Continuous Improvement and/or Lean experience highly preferred
• Ability to work M-F day schedule (7am to 4:30pm) with overtime as needed.