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Quality Engineer - 53342936 - TT

Job Code: 53342936
Job Location: Plymouth, MN
Category: Quality Engineering
Last Updated: 11/22/2016
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Job Description:
SUMMARY:
Provide quality engineering support to Manufacturing Operations and R&D by resolving quality-related issues, improving product quality, investigating customer complaints and reducing costs.  Utilize the our Correction and Preventive Action system to pursue continuous improvement of the our Quality System and products.  Assist with supplier support and play an active role in cost reduction projects that support Lean initiatives. Represent Quality Assurance on Research and Development project teams.  Support Manufacturing Engineering by reviewing validations as they relate to product quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards.
• Investigate/analyze in-house and field failures (complaints), and improve product quality by determining root cause and recommending corrective action.
• Propose, recommend, and oversee implementation of component and process improvements based on quality trends.
• Participate in investigation and analysis of customer complaints where necessary.
• Review and approve disposition for Nonconforming Product and participate in Material Review Board (MRB) team.
• Review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
• Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
• Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
• Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
• Be key participant in CAPA Committee and any Data Review Committees.
• Interface with personnel from all areas of the company to foster improved quality and reduced cost.
• Utilize QA Inspectors and Technicians as resources.
 
Requirements:
QUALIFICATIONS REQUIRED FOR POSITION:
• BS in Engineering (or equivalent) and a minimum of 5 years engineering work experience. BS EE preferred.
• Medical device industry as a Quality Assurance Engineer preferred.
• Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards.
• Must possess practical knowledge related to products that the position will support, e.g., electromechanical products.
• Must possess basic PC skills, and have working knowledge of Microsoft Word, Excel, and PowerPoint.
• Must have practical knowledge and experience in statistical analysis, SPC, and Root Cause Investigation.
• Must be able to properly use most inspection tools and test equipment.
• Must be able to read and understand component/product specifications.
• Ability to create and use Pivot Tables preferred.
PHYSICAL REQUIREMENTS:
• None    
IDEAL CANDIDATE PROFILE:
Personal Characteristics:
• Must be highly organized and have the ability to manage multiple projects concurrently.
• Must possess good written and verbal communication skills as well as team building skills  
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 53342936TT
 
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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