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Technician II

In Minnesota / United States

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Technician II   

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JOB TITLE:

Technician II

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Plymouth Minnesota / United States

JOB DESCRIPTION:

Performs or assists in performing quality assurance responsibilities in semi-routine to develop, apply, and maintain quality requirements for processing components and other materials into finished goods and products. Under limited supervision, works with quality assurance and manufacturing personnel to ensure effective inspection and testing procedures are implemented and maintained. Scope of responsibility is well defined, but requires some use of judgment. This is an intermediate level position. DUTIES/RESPONSIBILITIES: Familiar with and can apply principles of FDA Quality Systems Regulations and ISO 9001 Quality Systems Standards. Assists in the development and implementation of new inspection and testing procedures.. Assists in the development of limit samples that are used to determine if product meets quality specifications.. Reviews device history records to verify that information is correct and complete and that all specifications have been met. Employs Good Documentation Practices in all aspects of work. Periodically reviews existing inspection and testing procedures and provides input for engineering change orders (ECOs) as necessary. Understands the ECO system and can initiate an ECO. Ensures that product at all stages of inspection maintains proper identification, traceability, and inspection and test status. Assists in engineering projects, such as process validation, first article inspection, engineering studies, and other continuous improvement activities. Performs general receiving inspection, in-process, and final inspection of product, packaging and labeling. Conducts visual, dimensional and functional inspection and testing as directed by quality assurance procedures and other specifications. Performs physical testing such as packaging peel tests; polymer product break load and ultimate elongation. May perform moderately complex analytical testing such as LAL testing of processing water, FTIR testing of incoming materials, etc., per quality assurance procedure requirements. Ensures measurement, test and inspection equipment is calibrated and in good condition. May also maintain calibration program for measurement, test and inspection equipment. Generates nonconformance reports and follows through on disposition of nonconforming product. Understands the general types of defects and failure modes that can occur in product. Coordinates with production and materials control personnel to identify scope of and quarantinenonconforming product. Supports Quality Systems Manager or Engineer on corrective action, failure investigations and customer complaints. Maintains and archives quality control records. Participates in internal ISO/GMP audits. Assists Quality Systems Manager or Quality Systems Engineer in cross-training other QA Technicians. Assists Quality Systems Manager or Quality Systems Engineer in implementing statistical process control / statistical quality control programs. Employs statistical sampling techniques in routine inspection and testing activities. Performs other duties as required by the Quality Systems Manager or Quality Systems Engineer.

Position Details

POSTED:

Apr 18, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16438824081116

LOCATION:

Minnesota / United States

CITY:

Plymouth

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Technician II    Apply

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Performs or assists in performing quality assurance responsibilities in semi-routine to develop, apply, and maintain quality requirements for processing components and other materials into finished goods and products. Under limited supervision, works with quality assurance and manufacturing personnel to ensure effective inspection and testing procedures are implemented and maintained. Scope of responsibility is well defined, but requires some use of judgment. This is an intermediate level position. DUTIES/RESPONSIBILITIES: Familiar with and can apply principles of FDA Quality Systems Regulations and ISO 9001 Quality Systems Standards. Assists in the development and implementation of new inspection and testing procedures.. Assists in the development of limit samples that are used to determine if product meets quality specifications.. Reviews device history records to verify that information is correct and complete and that all specifications have been met. Employs Good Documentation Practices in all aspects of work. Periodically reviews existing inspection and testing procedures and provides input for engineering change orders (ECOs) as necessary. Understands the ECO system and can initiate an ECO. Ensures that product at all stages of inspection maintains proper identification, traceability, and inspection and test status. Assists in engineering projects, such as process validation, first article inspection, engineering studies, and other continuous improvement activities. Performs general receiving inspection, in-process, and final inspection of product, packaging and labeling. Conducts visual, dimensional and functional inspection and testing as directed by quality assurance procedures and other specifications. Performs physical testing such as packaging peel tests; polymer product break load and ultimate elongation. May perform moderately complex analytical testing such as LAL testing of processing water, FTIR testing of incoming materials, etc., per quality assurance procedure requirements. Ensures measurement, test and inspection equipment is calibrated and in good condition. May also maintain calibration program for measurement, test and inspection equipment. Generates nonconformance reports and follows through on disposition of nonconforming product. Understands the general types of defects and failure modes that can occur in product. Coordinates with production and materials control personnel to identify scope of and quarantinenonconforming product. Supports Quality Systems Manager or Engineer on corrective action, failure investigations and customer complaints. Maintains and archives quality control records. Participates in internal ISO/GMP audits. Assists Quality Systems Manager or Quality Systems Engineer in cross-training other QA Technicians. Assists Quality Systems Manager or Quality Systems Engineer in implementing statistical process control / statistical quality control programs. Employs statistical sampling techniques in routine inspection and testing activities. Performs other duties as required by the Quality Systems Manager or Quality Systems Engineer.


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