Quality Technician - Contract

Laborie Medical Technologies Corp•Plymouth, MN

11d

About The Position

Perform inspections and/or QC of supplier products (raw materials, subassemblies and finished goods) based on approved specifications, work instructions or procedures to meet Laborie's requirements and quality standards. Perform First Article Inspection (FAI) and prepares conformance reports based on approved specifications. Aid in the creation and revision of related procedures, processes, tests, inspections, and specifications. Support Non-Conforming Reports (NCRs) in accordance with an ISO 13485 quality management system. Assist quarantine area including labeling, segregating, and transacting quarantined items. Maintain document databases and filing systems for both electronic and hard copy documents. Work closely with production staff concerning quality discrepancies and provide feedback in support of preventative and corrective action activities. Facilitate external/internal calibrations of measurement equipment, scheduling with production and external providers as appropriate. Perform sampling for environmental monitoring and/or temperature and humidity monitoring and submit samples to external labs for evaluation or testing. This is a contract position.

Requirements

2 years of experience in a related position with a High School diploma
Strong organizational skills and attentive to detail, good communication skills
Basic understanding of inspection tools such as calipers, micrometers, and gauges
Proficiency in Microsoft Office applications
Knowledge of medical device quality and safety requirements
Exposure to ISO and FDA regulations desirable, ISO 13485 preferred

Nice To Haves

Exposure to ISO and FDA regulations desirable, ISO 13485 preferred

Responsibilities

Perform inspections and/or QC of supplier products (raw materials, subassemblies and finished goods) based on approved specifications, work instructions or procedures to meet Laborie's requirements and quality standards.
Perform First Article Inspection (FAI) and prepares conformance reports based on approved specifications.
Aid in the creation and revision of related procedures, processes, tests, inspections, and specifications.
Support Non-Conforming Reports (NCRs) in accordance with an ISO 13485 quality management system.
Assist quarantine area including labeling, segregating, and transacting quarantined items.
Maintain document databases and filing systems for both electronic and hard copy documents.
Work closely with production staff concerning quality discrepancies and provide feedback in support of preventative and corrective action activities.
Facilitate external/internal calibrations of measurement equipment, scheduling with production and external providers as appropriate.
Perform sampling for environmental monitoring and/or temperature and humidity monitoring and submit samples to external labs for evaluation or testing.