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Quality Engineer​/Medical - Injection Molding

Job in WI Wisconsin - USA
Company: Vet2Tech
Full Time position
Listed on 2019-06-11
Job specializations:
  • Engineering
    Manufacturing Engineer, Quality Engineering, Engineering Technology
  • Manufacturing
    Lean Manufacturing
Job Description & How to Apply Below
Position: Quality Engineer (Medical - Injection Molding)

Location: Baldwin

Job Description

QUALITY ENGINEER

JOB SUMMARY

Serve as a technical resource to Quality Assurance, Customers, Production, and Engineering relative to the interpretation and application of customer drawings, specifications, statistical monitoring systems, establish criteria for production and related systems. Develop and validate injection molding process, auxiliary process and assemblies.

JOB RESPONSIBILITIES:

  • Oversee/Coordinate various inspection functions including: Process capability studies, Gage R&R studies, Design of Experiments, Related inspection activities, Part and process validations
  • Review and advise on first article reports
  • Attend MRB and take part in disposition and root cause of MRB's
  • Lead validation / qualification activities o Develop protocol, validation reports and statistical analysis data
  • Develop quality criteria and measurement methods for new projects
  • Define product requirements which will fulfill the customer’s needs
  • Function as primary resource for the interpretation of customer drawings, standards and criteria
  • Implement Statistical Process Control techniques
  • Contribute and review Returned Goods, CAPA & Complaint activities and resolve quality issues
  • Work with suppliers on quality issues and support SCAR system
  • Participate and lead process improvement teams
  • Ensure highest possible product quality and adherence to the Company’s quality system, ISO and/or other standards
  • Support and comply with all ISO 9001, ISO 13485, and ISO 14000 Policies, Procedures, SOP’s, Work Instructions as they apply to the job classification or specifically assigned job and complete as directed all required training related to these standards
  • Adhere to all safety procedures
  • Maintain a clean and safe work environment
  • Perform other duties as assigned

JOB REQUIREMENTS:

  • Bachelor's degree or an Associate’s degree (A.A.), plus 6 years related experience and/or training; or an equivalent combination of education and experience is required
  • Minimum of 6 years’ experience in quality assurance activities in a plastics injection molding environment is desired
  • Experience with Statistical Process Control and ISO 9001, ISO 13485, and FDA experience desired
  • Knowledge of calibration procedures and techniques, first article, IQ/OQ/PQ validation of equipment and processes and mechanical inspection gauging systems (including CMM) is required
  • Blueprint reading ability, specification interpretation, communication skills, technical writing and knowledge of statistics and principles of quality methods are required
  • Ability to develop and manage projects  Knowledge of ISO 9001, ISO 13485, and FDA standards and requirements
  • Specific vision requirements of this job include close vision and color vision

PAY RATE: Commensurate with experience

JOB LOCATION: Baldwin, WI

If interested, please email a MS Word version of your resume to: (Please contact us using the "Apply for this Job Posting" box below)

Company Description

Vet2Tech is dedicated to connecting veterans and in many cases, qualified non-veterans with employment opportunities in manufacturing and technical careers nationwide.

Position Requirements
Less than 1 Year work experience
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