Quality Assurance Specialist
Description:
OverviewResponsible for performing incoming and outgoing inspections as well as maintaining the electronic documentation system / recordkeeping processes.
Inspects products, assists engineers, conducts tests, and collects data.
Principal Responsibilities Perform dimensional and visual first article and in-process/final inspection on raw material, parts, gages, and other equipment, accepting material/product or referring for quality review based on findings.
Prepare inspection reports; ensure material traceability.
Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
Use a variety of fixed and variable measuring instruments.
Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements.
Ensure compliance with electronic document control workflows.
Coordinate QA/QC tasks with cross functional teams across the organization:
support product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
Support and promote continuous improvement initiatives to meet business objectives.
Perform miscellaneous duties and projects as assigned and required.
Requirements:
Training, Skills, Knowledge and/or Experience Demonstrated ability to manage records, document controls, and change controls.
Experience using precision measuring equipment.
Experience interfacing with stockroom, production control, purchasing, and engineering personnel.
Working proficiency with Microsoft 365 apps, experience using ERP/MRP/PLM systems preferred.
Experience in FDA QSR and/or ISO 13485 or other regulated industry environments preferred.
Experience working in a product development environment a plus.
Experience with QMS internal auditing and Minitab usage a plus.
PI631cd50ec89e-31181-33287827 Recommended Skills Business Planning Business Process Improvement Change Control Corrective And Preventive Action (Capa) Engineering Change Order Enterprise Resource Planning Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
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open('/interstitial?jobdid=j3v3dg6dmh9ydy4xstb', 'ExternalApply-j3v3dg6dmh9ydy4xstb'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
OverviewResponsible for performing incoming and outgoing inspections as well as maintaining the electronic documentation system / recordkeeping processes.
Inspects products, assists engineers, conducts tests, and collects data.
Principal Responsibilities Perform dimensional and visual first article and in-process/final inspection on raw material, parts, gages, and other equipment, accepting material/product or referring for quality review based on findings.
Prepare inspection reports; ensure material traceability.
Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
Use a variety of fixed and variable measuring instruments.
Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements.
Ensure compliance with electronic document control workflows.
Coordinate QA/QC tasks with cross functional teams across the organization:
support product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
Support and promote continuous improvement initiatives to meet business objectives.
Perform miscellaneous duties and projects as assigned and required.
Requirements:
Training, Skills, Knowledge and/or Experience Demonstrated ability to manage records, document controls, and change controls.
Experience using precision measuring equipment.
Experience interfacing with stockroom, production control, purchasing, and engineering personnel.
Working proficiency with Microsoft 365 apps, experience using ERP/MRP/PLM systems preferred.
Experience in FDA QSR and/or ISO 13485 or other regulated industry environments preferred.
Experience working in a product development environment a plus.
Experience with QMS internal auditing and Minitab usage a plus.
PI631cd50ec89e-31181-33287827 Recommended Skills Business Planning Business Process Improvement Change Control Corrective And Preventive Action (Capa) Engineering Change Order Enterprise Resource Planning Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3v3dg6dmh9ydy4xstb', 'ExternalApply-j3v3dg6dmh9ydy4xstb'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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