Job Listing Description

THIS JOB IS NO LONGER AVAILABLE. THIS IS ARCHIVAL INFORMATION.
Quality Engineer - May 2023 - 1901

Description:
Quality Engineer - May 2023 - 1901 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 varsha@keltia-design.com with preferred pay requirements and availability and we will follow up immediately.

Job Number: KD 1901
Job Location: IA
Rate: OPEN
Per Diem: Possible
Overtime: Possible
Duration: LT
Start Date: ASAP
Input Date: 08/12/2024

Firm Name: KELTIA DESIGN INC
Attention: Kevin Burtchaell
Address: 2333 SEA WAY BLVD STE 212
City, State: EVERETT, WA 98203
Phone: 206/368-9812
Fax Phone: 206/237-8950
Website: www.keltia-design.com

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