Careers

This role is responsible for trimming plastic parts with a handheld trimmer in accordance with ISO13485 continuous improvement standards. The hours for this position are Friday-Sunday, 6:00PM-6:30AM. 

Essential Functions and Responsibilities:

• Handle small plastic injection molded parts with hands and complete projects in accordance with approved procedures
• Monitor and control assigned process, ensuring production activities are carried out in accordance with approved procedures and guidelines.
• Seek solutions for problems associated with assigned processes and communicate any identified defects in materials, damage, or concerns to Supervisor.
• Document any defects, damage or changes in specified logs according to work procedures.
• Ensure work areas are maintained in a clean and organized manner.
• Perform quality checks with appropriate measuring devices per job instructions.
• Look through microscope at small hand-held items throughout shift.

Education and/or Experience:

• Minimum of High School Diploma or equivalent
• Ability to read blueprints and use measuring devices
• Basic reading and math skills required
• Basic computer proficiency in MS Word and Outlook required
  
  

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This role is responsible for the safe and efficient operation of qualified production automation systems and machinery in accordance with approved procedures and guidelines in accordance with ISO13485 Continuous Improvement Standards. This role will perform process verification of tooling and instructions prior to starting machinery to ensure quality and efficiency. The hours for this position are Monday-Friday, 7:00AM-3:30PM.

Essential Functions and Responsibilities:

• Operate qualified production automation systems and machinery to complete assemblies and subassemblies
• Ensure quality and safe working practices are followed before, during, and after automation systems and machinery operations
• Handle small injection molded and purchased parts, subassemblies, assemblies, and tooling with hands and complete projects in accordance with approved procedures
• Ability to look through a microscope at small hand-held items as required
• Monitor and control assigned process, ensuring production activities are carried out in accordance with ISO13485 continuous improvement procedures and guidelines.
• Seek solutions for problems associated with assigned processes and communicate any identified defects in materials, damage, automation equipment issues, or concerns to Supervisor.
• Document any defects, damage, or changes in specified logs according to work procedures.
• Ensure work areas are maintained in a clean and organized manner.
• Maintain machine cycle times to meet scheduled customer delivery.
• Assemble, disassemble, and reassemble automation assemblies.
• Perform quality checks with appropriate measuring devices per job instructions.

Education and/or Experience:

• Minimum of High School Diploma or equivalent
• Minimum of 1-year Automation Systems Operation preferred
• Ability to read and interpret work instructions and use measuring devices
• Basic reading and math skills required
• Basic computer proficiency in MS Word and Outlook required
  
  

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This position is responsible for installing, adjusting, and aligning equipment to meet process conditions that ensure resin is of the highest quality for production. This role will conduct continuous improvement studies to access that conditions are consistent with ISO13485 standards. The hours for this position are Monday-Thursday, 3:00PM-1:30AM.

Essential Functions and Responsibilities:

• Perform molding trials as specified by the Project Engineer and establish molding processes that meet product specifications.
• Execute validation protocols per the requirements set forth by the Project Engineer.
• Evaluate molding processes and collaborate with Production Manager to update and improve techniques for quality, efficiency, safety, and productivity to ensure established performance standards and ISO13485 guidelines are met.
• Work collaboratively with Process Technicians and the Mold Set Up Tech to start presses and maintain quality during production runs, ensuring presses are loaded with proper material and dried correctly.
• Ensure production processes are within validated range and established guidelines.
• Ensure scrap is minimized and production time is within validated process parameters.
• Perform and record line clearances, and process start-ups, to verify that production processes are being carried out in accordance with validated processes and procedures.
• Communicate any identified defects, damage, press issues or concerns and the corresponding resolution to Production Manager.
• Troubleshoot molding processing issues as required.

Education and/or Experience:

• Associates degree in Mechanical Technology preferred
• Minimum of 3-5 years recent Process Technician experience preferred
• Minimum of 3-5 years experience with plastic resins and resin drying systems preferred
• Solid understanding of plastic injection molding processes that includes ability to identify when the process is deviating from the norm and ability to troubleshoot to find solution.
• Working knowledge of measurement equipment and basic blue print reading required.
• Certification in Plastics Injection Molding preferred
• Computer proficiency in MS Word and ERP systems preferred
• Knowledge of clean room practices preferred
• Solid understanding of ISO13485 or ISO9001 continuous improvement.

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This position contributes to project performance, verification of product/process conformance, and customer satisfaction by providing technical expertise and leadership in executing product assurance engineering activities throughout the project development lifecycle. This role also supports quality improvement activities and helps implement and maintain items within the Quality Management System (QMS). This is an exempt paid position, and the hours for this position are Monday-Friday, 7:00AM-3:30PM.

Essential Functions and Responsibilities:

• Draft and document quality procedures, instructions, inspection methods, control plans, and other product-related documentation.
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues as needed.
• Participate in internal and external audits.
• Support customer audits.
• Work with customers to understand and align all quality requirements.
• Assist Material Review Board (MRB) to ensure timely disposition of products while ensuring corrective and preventative actions meet regulatory requirements.
• Support continuous improvement initiatives.
• Manage and investigate customer complaints, including Device History Record (DHR) reviews.
• Other duties as assigned.

Education and/or Experience:

• Bachelor’s degree or equivalent education/experience required.
• Minimum of 3 years of experience in the Medical Device Industry.
• Familiarity with Quality Systems and regulatory agencies, preferably ISO 13485 and FDA 21 CFR 820
• Familiar with standard concepts, practices, and procedures within quality inspection.
• Computer proficiency in MS Word and ERP systems preferred
• Knowledge of clean room practices preferred

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It’s an exciting time to join our team, and we’re hiring for a Quality Engineering Technician. This position is responsible for supporting the activities of the Quality department to ensure compliance to all customer and regulatory requirements through the Quality Management System (QMS). This role will assist in the improvement and maintenance of the QMS while supporting ISO13485 standards. The hours for this position are Monday-Friday, 7:00AM-3:30PM.

Essential Functions and Responsibilities:

• Coordinate CAPA activities within QMS procedures
• Perform calibration system administration
• Train others to established procedures
• Perform First Article inspections
• Perform Gage R&R studies
• Assist in the development and writing of procedures
• Recommend adjustments to the assembly or production process
• Inspect, test, or measure materials or products being produced
• Measure products with CT scanner, calipers, gauges, micrometers, vision systems, or other measurement equipment
• Discuss inspection results with those responsible for products
• Assist in the improvement and maintenance of the Quality Management System
• Draft new procedures and revise existing one to conform to what is required by process
• Supports Isometric ISO13485 continuous improvement initiatives
• Other duties as assigned

Education and/or Experience:

• Associate’s degree in related technical field, or 2+ years of relevant experience required
• Understand print and specification reading processes with GD&T concepts
• Ability to inspect a variety of equipment & methods experience
• Medical molding and validation experience preferred
• Independent initiative required
• Ability to work in a procedure-based system and follow guidelines
• Detail and Quality oriented
• Knowledge of clean room practices preferred
• Solid understanding of ISO13485 or ISO9001 continuous improvement
  
  

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We’re hiring for a Quality Inspector 1 – 2nd Shift. This position is responsible for performing quality control inspections, checks, and tests during the manufacturing process of products. This position will also inspect materials, parts, and products at different stages of production, while recording observations and making recommendations for improving processes. This role will conduct continuous improvement studies to access that conditions are consistent with ISO13485 standards. The hours for this position are Monday-Thursday, 3:00PM-1:30AM.

Essential Functions and Responsibilities:

• Inspect, test or measure materials or products being produced.
• Read Mechanical drawings and product specifications.
• Monitor production products and processes to ensure they meet quality standards.
• Recommend adjustments or improvements to the assembly or production process.
• Communicate with process technicians and/or production supervisors promptly upon non-conforming or marginal quality inspections.
• Measure products with rulers, calipers, gauges, micrometers, vision systems, or other measurement equipment.
• Communicate through daily quality pass down.
• Record and/or report inspection and test data.
• Supports continuous improvement initiatives.
• Other duties as assigned.

 
Education and/or Experience:

• High School Diploma or GED required, and 2+ years of quality experience preferred
• Familiar with standard concepts, practices, and procedures within quality inspection.
• Relies on limited experience and judgement to plan and accomplish goals.
• ​​​​​​​Computer proficiency in MS Word and ERP systems preferred
• Knowledge of clean room practices preferred
• Solid understanding of ISO13485 or ISO9001 continuous improvement.

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