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