Quality Engineer - Orange City - Keltia Design

    Keltia Design
    Keltia Design Orange City

    1 week ago

    Description
    Quality Engineer - May IA & Pacific Northwest
    Our client in IA & Pacific Northwest needs Quality Engineer who shall be responsible for the support of the Organization in its quest to produce quality products that meet customer requirements as well as statutory and regulatory requirements. The QE will also work to continually improve our processes and support the quality management system while maintaining the documentation system via adherence to Quality Assurance Procedures to ensure that the Quality System is compliant to national and internal standards.

    Essential Functions
    • Document Control - write ISO documentation and maintain same within the facility, with regard to ISO 90001, ISO 13485, AS9100, and 21CFR part 820
    • Process DCO's, ECN's, maintain revision control on documentation
      • BOM Control - update BOM's per ECN's and other inputs, update quality planning accordingly
    • Draft quality plans for new products and tests (IP Sheets)
    • Conduct Internal Audits and issue audit reports as Lead Auditor
    • Participate in 3rd party audits , including customer, Notified Bodies and Regulatory Agencies
    • Answer customer Quality System audits and surveys, prepare for registrar audits
    • Records retention for all products
      • Maintain Quality Planning per part
    • Prepare for semi-annual Management Reviews - coordinate preparations, contribute supporting info, write meeting minutes
    • Train per the Training Master List, for each new and revised document
    • Prepare data and info for customer visits
    • Maintain raw material certs, and the Material Certification List
    • Maintain Supplier Surveillance program
    • Record archives and obsolescence.
    • Initiate corrective action by drafting the CAR, PAR or SCAR
    • Coordination and records maintenance for Cleanroom testing, raw materials and or finished products, as required.
    • Preparation of data and reports to senior management upon request.
    • Maintain Calibration system for equipment
    • Create IQ/OQ/PQ Protocols and summary reports to provide to customers.
    • Create and Execute Software Validations
    • Utilize Minitab to populate data for part summary reports.
      • All other duties as assigned.
    • Supervise / Support metrology and inspection resources
    Job Requirements
    • Candidates must be a "US Person" (i.e. US Citizen or Permanent Resident) to ensure our client's compliance with ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations)
    • B.S. in Engineering discipline (preferably Bio-Medical, Mechanical or Industrial), or equivalent on-the-job experience (minimum 10 years)
    • Experience in AS9100, Aerospace and Defense Manufacturing is required.
    • Knowledgeable of document control methodologies is required.
    • Thorough knowledge of ISO and cGMP requirements. i.e. AS9100, ISO9001, ISO13485
    • Internal Auditor experience
    • Use of standard and automated metrology equipment
    • GD&T blueprint reading is required
    • Knowledgeable in plastics processing, manufacturing, or tooling design environments is desirable
    • ASQ certification is desirable
    If interested, please send your updated resume in Word doc format to Varsha at - with preferred pay requirements and availability and we will follow up immediately.

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