Ensure strict compliance to all ISO9001 and ISO13485 Quality Management System related standards.
Assist Director of Quality in maintaining the Quality Management System, including the conducting of internal process audits, and the control of quality documentation and records.
Act as liaison with customers to process complaints, and assessing product returns.
Support Quality Control by performing own inspections; ensuring that products and processes comply with relevant specifications and requirements.
Design and implement specialized inspection tooling and methods in support of the manufacturing and inspection processes.
Manage supplier corrective / preventive actions.
Analyze product/process failure, perform root cause analysis, and implement appropriate corrective/preventive action.
Create and maintain quality documentation, such as procedures, inspection plans, work instructions, quality assurance specifications, etc.
Perform other duties as assigned.
Job
Type
Full time
Salary
$65 to $75 Per Year
Responsibilities
• Ensure strict compliance to all ISO9001 and ISO13485 Quality Management System related standards.
• Assist Director of Quality in maintaining the Quality Management System, including the conducting of internal process audits, and the control of quality documentation and records.
• Act as liaison with customers to process complaints, and assessing product returns.
• Support Quality Control by performing own inspections; ensuring that products and processes comply with relevant specifications and requirements.
• Design and implement specialized inspection tooling and methods in support of the manufacturing and inspection processes.
• Manage supplier corrective / preventive actions.
• Analyze product/process failure, perform root cause analysis, and implement appropriate corrective/preventive action.
• Create and maintain quality documentation, such as procedures, inspection plans, work instructions, quality assurance specifications, etc.
• Perform other duties as assigned.
Required Skills
• Proficient knowledge of GD&T Management of multiple simultaneous pricing efforts.
• Experience using QCCalb and MiniTab
• Experience with ISO9001 and ISO13485
• Experience internal ISO9001 and ISO13485
• Experience with RMA process
• Experience with 8D root cause analysis
• Knowledge of SPC process and Gage R&R
• Knowledge of MS Excel, Word, and PowerPoint.
• Strong communication skills necessary for interfacing with both internal and external customers and suppliers
• Good documentation skills for capturing inspection results against drawings, specification requirements
8 – 10 years estimating experience in a machine shop environment
Engineering Degree of equivalent
Zeiss CMM with Calypso programming experience
Experience supervising mechanical inspectors
Experience with 5S
Training as a Lead ISO internal auditor
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