Rewarding Careers

SUMMARY OF DUTIES: Our Administrative Assistant will be responsible for all aspects of daily front office operations including clerical tasks, answering calls, quotes, correspondence, filing, greeting visitors and vendors, reports, scheduling meetings, travel, copies, mail, ordering supplies, maintaining equipment maintenance and special projects.

ESSENTIAL DUTIES: Supports senior managers and executives with daily clerical tasks.
Answer phone calls, provide information to callers or routes call appropriately.
Social media posting preparation.
Types company quotes for customers.
Composes and types routine correspondence.
Organizes and maintains file system, customer database and files correspondence of other records.
Greets and processes visitors and vendors.
Arranges and coordinates travel schedules and reservations.
Coordinates and arranges meetings, updates calendar, prepares agendas, reserves and prepares facilities.
Duplicates correspondence or other printed materials.
Prepares emails, faxes and outgoing mail.

EDUCATION LEVEL: • High school diploma and 5 years of administrative assistant experience

EXPERIENCE: Knowledge of appropriate software including: Microsoft Word, Excel, and Outlook, Microsoft PowerPoint and Adobe Acrobat

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: Prepare components for the assembly of medical guidewire devices to include final customer packaging.

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: one to three months related experience.

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: 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: 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: The shipping clerk sees to it that accurate records are kept of all products received and shipped. Additionally, the incumbent is tasked with updating and providing accurate records of inventory. Weigh and track shipments and see to it that products react the desired location promptly. The shipping clerk works closely with management by creating reports and actively monitoring inventory while keeping precise records.

ESSENTIAL DUTIES: • Obtain and process product orders, including receiving deliveries, registering them and distributing packages and letters within the company
• Maintain the company stockroom through organizing, cleaning and cataloging items on a regular basis
• Schedule large shipments and plan logistics to ensure that there is sufficient storage space for incoming items and staff on hand to manage the shipments
• Keep files of goods shipped and received by preparing regular shipping and receiving reports for managers
• Ensure adherence to environmental management and systems
• Trouble shoots shipping issues and customer complaints that arise and work to solve them
• Place merchandise in a warehouse or storage facility by packaging, lifting items as necessary, operating forklifts and pallet jacks for large goods
• Keep management and supervisors aware of product shortages in order to maintain accurate information on the company website
• Organize stock and merchandise with in the warehouse by properly boxing and storing goods in their designated location
• Practice customer service when interacting with other companies and clients and see to it all external parties receive a positive interaction with the company
• Verify all incoming shipments to be accurate by comparing the invoice to order and ensuring all goods are in acceptable condition
• Accurately package, label and weigh items to be shipped and ensure proper shipment method and shipping charges
• Prepare detailed and accurate invoices to accompany shipments and ensure all items are packaged and shipped to company standards
• Work with other shipping clerks to see that all invoices are handled promptly, and goods are shipped and stored properly

EDUCATION LEVEL:

EXPERIENCE: • High school diploma, GED, or equivalent
• 6 months logistics, retail, or customer service experience
• Forklift Certification within 90 days of job entry date
• Familiarity with Radio Frequency (RF) equipment
• Strong interpersonal and communication skills
• Excellent organization and administrative skills
• Integrity and leadership skills
• Exemplary customer care skills
• Good analytical and problem solving skills
• Strong computer skills
• Ability to operate warehouse machinery such as forklifts
• Detail-oriented and multitasking skills
• Ability to lift up to 50 pounds, as many packages are large
• Experience working in a fast-paced environment while maintaining attention to detail
• Ability to maintain a high level of physicality for prolonged periods and working primarily standing
• Experience with software such as Microsoft Excel and other company spreadsheet programs
• Interpersonal skills are essential, as working as a team is vital to maintaining an organized warehouse
• Ability to problem solve quickly and prioritize daily tasks according to their importance
• Personal accountability and integrity are paramount, as a shipping clerk is tasked with an accurate accounting of all inventory
• Relevant customer service experience is a plus as shipping clerks interact with customers to replace lost or damaged goods

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.