Quality Inspector
Our Milpitas, CA client seeks a Quality Inspector.
This is a full time permanent role.
Must have skills:
Medical Device Experience Documentation/Batch Records - Mostly Manual Documentation Calibration Test QA/QC Background Working Hours:
Monday - Friday 8am - 5pm
Responsibilities:
Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.
Maintain up-to-date DHR/LHR files, including electronic versions.
Prepare sterile disposable product for shipment to sterilizer, including all necessary / asncillary paperwork.
Assist in management of the equipment calibration/PM program, to include induction of new equipment into the program, sending equipment out for calibration/PM, proper documentation/stowage of inactivated equipment, and maintenance of records.
Assist in management of the Controlled Environmental Area (CEA), including scheduling service and reviewing & reacting to various reports/records -- e.
g.
, environmental monitoring reports, product bioburden reports, cleaning records, and differential pressure monitoring records.
Perform final inspections, including Power-On-Self-Testing (POST) and visual inspection of finished medical devices prior to release.
Perform monthly electrostatic discharge control (ESD) tests and maintain ESD logs for Mfg, CEA, R&D, IQC, and stockroom.
Assist in maintenance & management of various QMS subsystems -- including, but not limited to Environmental Monitoring, Service Record Processing, Non-Conforming Material Handling, Manufacturing Deviation Authorizations, and Rework Orders.
Other duties as may be assigned.
Skills &
Qualifications:
Minimum high school diploma.
An organized, analytical thinker with exceptional attention to detail.
An excellent communicator, both oral and written.
Capable of interpreting data, identifying root causes.
Working knowledge of Microsoft Office.
Working knowledge of 21CFR820 and ISO 13485.
2-4 years of relevant work experience.
Recommended Skills Calibration Documentation Medical Device Quality Assurance Quality Control Estimated Salary: $20 to $28 per hour based on qualifications.
This is a full time permanent role.
Must have skills:
Medical Device Experience Documentation/Batch Records - Mostly Manual Documentation Calibration Test QA/QC Background Working Hours:
Monday - Friday 8am - 5pm
Responsibilities:
Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.
Maintain up-to-date DHR/LHR files, including electronic versions.
Prepare sterile disposable product for shipment to sterilizer, including all necessary / asncillary paperwork.
Assist in management of the equipment calibration/PM program, to include induction of new equipment into the program, sending equipment out for calibration/PM, proper documentation/stowage of inactivated equipment, and maintenance of records.
Assist in management of the Controlled Environmental Area (CEA), including scheduling service and reviewing & reacting to various reports/records -- e.
g.
, environmental monitoring reports, product bioburden reports, cleaning records, and differential pressure monitoring records.
Perform final inspections, including Power-On-Self-Testing (POST) and visual inspection of finished medical devices prior to release.
Perform monthly electrostatic discharge control (ESD) tests and maintain ESD logs for Mfg, CEA, R&D, IQC, and stockroom.
Assist in maintenance & management of various QMS subsystems -- including, but not limited to Environmental Monitoring, Service Record Processing, Non-Conforming Material Handling, Manufacturing Deviation Authorizations, and Rework Orders.
Other duties as may be assigned.
Skills &
Qualifications:
Minimum high school diploma.
An organized, analytical thinker with exceptional attention to detail.
An excellent communicator, both oral and written.
Capable of interpreting data, identifying root causes.
Working knowledge of Microsoft Office.
Working knowledge of 21CFR820 and ISO 13485.
2-4 years of relevant work experience.
Recommended Skills Calibration Documentation Medical Device Quality Assurance Quality Control Estimated Salary: $20 to $28 per hour based on qualifications.
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