Quality Technician

Location: Plymouth, Minnesota
Posted On: 9/7/2017
Job Code: QT_MN2128
Job Description
2nd shift (2-10pm)
Position Purpose:
• The general purpose of this position is to provide quality support to the manufacture of client products on 2nd shift with limited direct supervision. The position will work with Operations personnel ensuring that client products are manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirement.
• Lead/assist investigations into non-conforming material including definition of scope, investigation into root cause, disposition of product, and implementation of corrective actions.
• Conduct process audits in accordance with internal/external requirements.
• Assist in scrap evaluation and defect reduction.
• Provide guidance to manufacturing through interpreting manufacturing/inspection procedures, engineering drawings, and component specifications.
• Generate reports of activities.
• Provide technical support for testing, qualifications, and validations.
• Ability to take direction from multiple persons and work effectively with cross-functional team members.
• Comply with applicable FDA and international regulatory laws/standards and the client Code of Conduct.
• Understanding of operations objectives and ability to work with team members to achieve
• Use time and resources efficiently
• Maintain work area in a neat and organized manner
• Perform duties within acceptable quality, per Standard Work, and in a safe manner
• Ability to lead change and influence others
• Self-directed: Ability to take on assignments and drive independently to successful closure
• Good working relationships with Engineering and Quality staff
• Other duties as assigned or required
• Participate, support and advise manufacturing, development and engineering teams with product changes related to microbiology testing, biocompatibility testing, and sterilization validation.
• Review and approve changes to manufacturing, quality and inspection procedures and specifications.
• Manage the disposition of nonconforming material and assemblies as necessary for Microbiology/Sterilization.
• Generate ECO’s and purchase requisition as needed

Required Knowledge and Skills:
• Two-year technical degree required. Work experience may be considered in lieu of technical degree.
• Medical device industry experience preferred.
• Familiar with basic statistical tools, i.e. average, standard deviation, control charts, and Cpk.
• Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet in a network environment.
• Experience with SPC preferred.
Category:IT  code:new
Job Requirements
Cloud Computing, Engineering, MS Word, Direct3D, STE, SPC, COM, Technical Support

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Contact Details
Ebrahim Sayarwala