Job Information
Belcan Quality Engineer in Agawam, Massachusetts
Quality Engineer
Job Number: 349326
Category: Quality Engineering
Description: 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.
All other duties as assigned.
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
Location: Agawam , MA
Minimum Experience (yrs): 10+
Required Education: Bachelor (BA, BS...)
Benefits:
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