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Quality Engineer

4 months ago

Agawam, United States Belcan Full time

Job Title: Quality Engineer

Location: Agawam, MA

Zip Code: 01001

Start Date: Right Away

Job Type: Contract

Pay Rate: $50.00 - $60.00/hr DoE

Schedule: Hybrid

Keywords: #QualityEngineer #EngineeringJobs #ISOproducts


JOB RESPONSIBILITIES:

  • 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.
  • Supervise / Support metrology and inspection resources


REQUIRED QUALIFICATIONS:

  • B.S. in Engineering discipline (preferably Bio-Medical, Mechanical or Industrial), or equivalent on-the-job experience with minimum of 10 years
  • IQ/PQ background and validations experience
  • 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 knowledge is required
  • Knowledgeable in plastics processing, manufacturing, or tooling design environments is desirable
  • ASQ certification is desirable


If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com

EOE/F/M/D/V