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. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
COMPUTER SKILLS:
To perform this job successfully, an individual should have knowledge of: Spreadsheet Software (Excel); Word Processing Software (Word); Electronic Mail Software (Outlook). General ERP and PLM understanding Benefits
Nextern?is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Function: IT/Computers - Software & Software Services
Job Type: Full Time
Workplace Type: On-site
Experience Level: Associate
Salary: Competitive & Based on Experience
Experience: 0 - 0 yrs
Company about us: Nextern is a leading medical device company that partners with innovators, clinicians, and device partners to bring cutting-edge medical devices to the market. With a strong focus on collaboration and innovation, we work with our partners to create, iterate, optimize, and manufacture best-in-class medical devices. Our unmatched core competence in...
Company Name: Nextern
Recruiting People: HR Department
Website: http://www.nextern.com
Headquarter: Maple Grove, Minnesota, USA 55369
Industry: Medical Devices / Equipments
Company Size: 201-500 Employees
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