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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.
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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
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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.
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SUMMARY OF DUTIES: • Plans and coordinates work assignments based on skills, knowledge, experience, man hours, machines, and tooling to the best advantages to obtain the most favorable outcomes with costs, quality and workmanship.
• Analyzes maintenance problems. Recommend measures to improve facility.
• 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.
• Plans, budgets, and schedules facilities modifications including cost estimates, bid sheets, layouts, and contracts for construction and acquisitions.
• Oversees proper operation of generator and all appropriate paperwork.
• Formulates and coordinates program specifications, requirements for proposals and contracts, and associated documents.
• Ensures that the facilities building & grounds are maintained, including the cleanliness attached to all areas, both in & outdoors to decrease potential safety hazards.
• Acts as liaison to all contractors, public utility, environmental, and energy agencies.
• Inspects construction and installation progress to ensure conformance to established specifications.
• Oversees the coordination of building space allocation, layout, and communication services.
• Oversees and directs maintenance personnel and workers engaged in equipment installation, facilities equipment repair, preventive and grounds maintenance.
• Maintains required paperwork.
• Heads up safety committee, follows as well as enforces company policies, safety rules and regulations to employees.
• Meets with hourly employees to help resolve any maintenance issues.
• Trains assigned employees based on knowledge of identified training needs, company production processes, and procedures.
• Studies blueprints, sketches, drawings, manuals, specifications, or sample part to determine dimensions and tolerances of finished workpiece, sequence of operations, and setup requirements.
• Measures, marks, and scribes dimensions and reference points on material or workpiece as guides for subsequent machining.
• Selects, aligns, and secures holding fixtures, cutting tools, attachments, accessories, and materials on machines such as mills, lathes, jig borers, grinders, and shapers.
• Calculates and sets controls to regulate machining factors such as speed, feed, coolant flow, and depth and angle of cut, or enters commands to retrieve, input, or edit computerized machine control media.
• Starts and observes machine operation to detect malfunctions or out-of-tolerance machining, and adjusts machine controls or control media as required.
• Operates welding equipment to cut or weld parts.
• Keep current on new techniques and equipment.
• Ensure clear, concise and effective communication between shifts.
• Snow removal and sanding of parking lot, walk ways and staircases.
• Inspects facility periodically to determine problems and necessary maintenance.
• Prepares weekly maintenance schedules and allocates work.
• Assists with recruiting, supervising and training maintenance technicians.
• Performs other duties as assigned.
ESSENTIAL DUTIES:
EDUCATION LEVEL: • High school diploma or equivalent required (see below)
EXPERIENCE: • Ten years related experience and/or training; or equivalent combination of education and experience.
• Knowledge of various crafts/ trades.
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