Quality Assurance Technician 2

Acumed; Lincoln (NE); On-site; USD 40,000 - 55,000; Full time

Job summary

Acumed is seeking a Quality Assurance Technician 2 to join their team in Lincoln, Nebraska. This role involves inspecting products and processes to ensure compliance with specifications. The ideal candidate will have relevant certifications in quality assurance, experience in mechanical inspection, and the ability to analyze and improve inspection methods. Join a global organization committed to making a positive impact in the medical equipment industry.

Qualifications

• 2 years of prior experience in mechanical inspection.
• Ability to read and speak English sufficiently for instructions.
• Understanding of ISO13485 and FDA 21 CFR 820 regulations.

Responsibilities

• Inspect material, products, or processes according to specifications.
• Perform first article inspections and auditing.
• Document non-conformance and coordinate calibration.

Skills

Quality Assurance

Mechanical Inspection

Problem Solving

Education

HS Diploma/GED or equivalent

Quality Technician Certification (CQT)

Quality Inspector Certification (CQI)

Tools

Precision Measuring Equipment

GIS and Tolerancing

MS Office

SAP

Job description

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Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Job Scope

The QA Technician 2 inspects material, products, or processes, purchased or manufactured, to the required drawing or print specification, inspection plan or other controlling documents. Documents out of specification situations by initiating nonconformance reports; performs cursory investigation. Performs in depth inspection of pilot run product and completing First Article Inspections. Makes recommendations to improve systems and processes, inspection methods and inspection standards to ensure all products meet requirements. Trains others in inspections techniques and best practices and performs calibration coordination for assigned work cells.

Shift

Day Shift, Monday – Thursday 5:00am-3:30pm

Requirements

• Tests, inspects, or measures products, materials, and/or processes to evaluate conformance with specifications.
• Performs first article inspection run inspection of dimensional features and performs documentation reviews.
• Conducts QA/QC activities including investigating non-conforming product/material.
• Supports the development and execution of process validation by testing processes and making recommendations for improvement.
• Supports the development and implementation of inspection plans; makes recommendations for improvements on input from QA Technicians.
• Audits in-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness.
• Evaluates processes for improvement using problem solving and improvement techniques and makes recommendations to Quality Engineer.
• Actively participates in Manufacturing Cell teams as a Quality representative by addressing quality-related issues per documented processes.
• Accurately enters information into manufacturing data gathering system.
• Creates Non-Conforming Material Reports as needed for out of specification, discarded or rejected products, materials, or gages. Dispositions materials following completion.
• Determines inspection priorities, monitors cell throughput, and tracks the status of receiving inspections by using and following established methods (Hot List, FIFO).
• Participates in activities which identify and reduce non-value-added processes (apply lean concepts).
• Trains new hires on inspection techniques and the correct use of gages and other inspection equipment.
  
  

Qualifications

• HS Diploma/GED or equivalent.
• Quality Technician Certification (CQT) or Quality Inspector Certification (CQI) from the American Society for Quality (ASQ) and/or 2 years of prior experience in mechanical inspection.
• Ability to read and speak English sufficiently to read work instructions, specifications and procedures and complete all paperwork and communicate with other employees.
• Experience with the use of precision measuring equipment including micrometers, calipers, gage pins, optical comparators, and other inspection equipment.
• Understanding of final acceptance activities.
• Proficient in reading and understanding engineering drawings and specifications.
• Proficiency with MS Office required.
• Proficiency in reading and interpreting Geometric Dimensioning and Tolerancing (GD&T).
• Experience with the use of manufacturing data gathering system to determine product status and location (SAP experience preferred).
• Knowledge of machining processes.
• Knowledge/understanding of ISO13485 (current revision) and FDA 21 CFR 820 regulations.
  
  

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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