Quality Engineer - Agawam, United States - Belcan

Belcan Agawam, United States

2 weeks ago

Description

Quality Engineer

Job Number:

Category: Quality Engineering

Description: Job Title: Quality Engineer

Location: Agawam, MA

Zip Code: 01001

Start Date: Right Away

Job Type: Contract

Pay Rate: $ $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

EOE/F/M/D/V

Location: Agawam , MA

Minimum Experience (yrs): 10+

Required Education: Bachelor (BA, BS...)

Benefits:

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