Johnson Electric Quality Assurance Associate - Medical Devices 

United States, Illinois 

946910077

The

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: