Nextern
medical devices
QualityTechnician
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“Quality Technician at Nextern. Skills: quality control standards, testing techniques, production and process control compliance, manufacturing Device History Record (DHR) review. ensuring production and process control compliance during the development and manufacturing of medical devices. direct monitoring and correction/training of production staff”
What You'll Achieve.
ensuring production and process control compliance; quality assurance of product conformance
Industry & Context.
Ability to define problems, collect data, establish facts, and draw valid conclusions
Demonstrates safe work habits, maintains clean and safe work area
What They're Looking For.
Must Have
Working knowledge of quality control standards and testing techniques, Ability to read, analyze, and interpret procedures and engineering drawings that are in English, Ability to compute rate, ratio, and percent and to draw and interpret bar graphs, Ability to define problems, collect data, establish facts, and draw valid conclusions, Knowledge of Spreadsheet Software (Excel), Knowledge of Word Processing Software (Word), Knowledge of Electronic Mail Software (Outlook), General ERP and PLM understanding
Nice to Have
Three-year relevant experience desired
What You'll Do.
ensuring production and process control compliance during the development and manufacturing of medical devices
direct monitoring and correction/training of production staff
Perform comprehensive manufacturing Device History Record (DHR) review at close of manufacturing process and product release
Makes decisions on how to handle product issues with the operator accordingly and matters pertaining to whether or not product is acceptable
Identifies and evaluates procedures to ensure the production of quality product during manufacturing
Provides the Quality group with technical support as required
May write technical reports and other required quality documentation
How You'll Work.
Team & Collaboration
Ability to effectively present information and respond to questions from co-workers and managers; Provides the Quality group with technical support as required
Communication Scope
Excellent verbal and written communication skills; Ability to effectively present information and respond to questions from co-workers and managers; Ability to write detailed reports and other technical documents
Full Job Description
SUMMARY: This position is responsible for ensuring production and process control compliance during the development and manufacturing of medical devices at the Nextern Maple Grove facility. This position may also involve quality assurance of product conformance for dimensional, electrical, and visual workmanship standards in accordance with requirements. DUTIES AND RESPONSIBILITIES: · Responsible for ensuring production and process control compliance during the development and manufacturing of medical devices. Including, but not limited to, direct monitoring and correction/training of production staff. · Perform comprehensive manufacturing Device History Record (DHR) review at close of manufacturing process and product release. · Makes decisions on how to handle product issues with the operator accordingly and matters pertaining to whether or not product is acceptable. · Identifies and evaluates procedures to ensure the production of quality product during manufacturing. · Provides the Quality group with technical support as required. · May write technical reports and other required quality documentation. · Demonstrates safe work habits, maintains clean and safe work area. · Willingness to provide and receive constructive input and feedback. · Other duties as needed SUPERVISORY RESPONSIBILITIES: · This job has no supervisory responsibilities. **Requirements** QUALIFICATIONS: · Three-year relevant experience desired. · Working knowledge of quality control standards and testing techniques. · Excellent verbal and written communication skills. LANGUAGE SKILLS: · Ability to read, analyze, and interpret procedures and engineering drawings that are in English. Ability to effectively present information and respond to questions from co-workers and managers. · Ability to write detailed reports and other technical documents. MATHEMATICAL SKILLS: · Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Abili
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