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Quality Tech - 57420991 - JL

Job Code: 57420991
Job Location: Minnetonka, MN
Category: Technicians
Last Updated: 06/13/2017
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Job Description:
Primary role will be documentation review of finished good product for product release. Secondary role will be paper trace form review for compliance to sit level procedures. Other tasks may include: incoming inspection and in-process testing and documentation review to support manufacturing. Skills needed include: attention to detail, close adherence to procedures, ability to be flexible in their daily work, ability to work independently and in a team environment. Preferred background is: Medical device, knowledge of the Quality System.
To provide quality support to product development and manufacturing. To develop, apply, monitor, measure, improve, and communicate quality methodologies from product development through product commercialization
Key Responsibilities -
• Perform documentation review of finished good product for product release
• Perform paper trace form review for compliance to sit level procedures
• Perform project and product testing.
• Perform basic statistical analysis and communicate results to teams.
• Contribute support for CAPA activities.
• Identify areas of improvement and participate in continuous improvement projects.
• Perform testing, gather and record data, analyze results and report product and in-process monitoring test results.
• Assist with process and product qualification activities.
• Assists during audit activities.
• Assist with product failure analysis.
• Create and maintain data files and forms.
• Use documentation systems to research information and generate Change Requests.
• Assist in developing and qualifying test methods, data sheets, test fixtures, and testing equipment.
• Train peers on processes and methods.
• Initiate and assist in the investigation and disposition of nonconforming materials, designs and/or systems.
• Review device history records (DHR) and acceptance records to ensure all activities in the Device Master Record (DMR) have been performed and approved.
• Update databases and spreadsheets used to track, monitor, and report department activities.
• Use the inventory and traceability management systems to transact and research material.
• Communicate with a wide variety of their personnel in and outside of the plant.
 
Requirements:
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
 
Qualifications:
AA Degree or equivalent work experience in related discipline and 1 year of related experience.
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or Plymouth@entegee.com.
 
Please reference job # 57420991JL
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 
 

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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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