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Johnson Electric Quality Engineer - Medical Devices 
United States, Illinois 
407793056

18.08.2024

Quality Medical Device Engineer
squality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.

Your responsibilities will be:

  • Ensure customer and regulatory requirements are met along the product development cycle.

  • Develop and implement medical quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures asrequired.

  • Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or otherappropriate qualitytools to define and manage risk oridentifyroot cause of failure.

  • Assistand/or complete with theresolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions.

  • Assistin development, review and approval of process and equipmentvalidation/qualifications(IQ, OQ, PQ). Develop,reviewand improve inspection plans, standard work sheet and product drawings.

  • Work oncontinuous improvement activities. Support Kaizen activities and re-work/scrap reduction.


Our Requirements

  • Bachelor's degree

  • Local Candidate Required

  • The right to work in the United States without Sponsorship

  • 1+ Years' experience in a medical device Manufacuring setting not including Internship and Co-Op experience

  • Familiarity with quality tools i.e. Gage R&R/MSA, calibration, NCMR, Root Cause Analysis and related problem-solving techniques, FMEA, FTA, Fish Bone Diagram, risk analysis

  • Experience with FDA regulations and ISO 13485

  • Experience with creating validations

What We offer:

JE offers talented employee’s exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.