Rewarding Careers

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: 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: 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: 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: 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: Job Summary:

Tests and inspects products at various stages of production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products by performing the following duties.
Essential Duties and Responsibilities:

Ability to interpret drawings and specifications.
Selects products for tests at specified stages in production process, and tests products for 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 nondestructive 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.
To discontinue further processing and delivery of non-conforming products until the discrepancy or non-conforming condition has been corrected.
To initiate actions to prevent the occurrence of product non-conformity.
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: Associates Degree 3 years experience in and/or related experience and/or training

EXPERIENCE: 3-5 years

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: 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: Able to set-up and or operate one or two types of Springmaking equipment, restock equipment. Makes only simple adjustments.
Set up Operator should be able to set up most CNC or mechanical machines.

ESSENTIAL DUTIES: Set Up/ Operate spring making equipment. Work independently.

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.