Quality Engineer 2

Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 241138
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Job Description:



Position Overview


 


The Quality Engineer 2 will assist in Nonconforming Material activities at the Flanders Facility, responsibilities including the containment, disposition and trending of non-conformances. In this role, he/she will interface with Procurement, R&D, Engineering and Operations to ensure that nonconforming material is controlled and dispositioned in accordance with approved processes and data.


Responsibilities


 


·        Support established production processes, by participating at daily production and weekly quality meetings.


·        Investigate, and disposition nonconforming material via MRB processes utilizing the SAP Quality Module.


·        Gathering and analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel.


·        Leading and participating at cross functional material review boards (MRB).


·        Determination of root cause analysis and implementation of corrective action for process related concerns.


·        Analyze failure, corrective and preventive action to respond to customer complaints.


·        Initiate, execute, review and approve changes via change control process


·        Assist Quality manager in establishing, implementing and maintaining the quality management system


·        Provide support by performing internal audits and participating in external audits


·        Support test method validation and gage R&R studies




 


Required Knowledge/Skills, Education, and Experience


 


·        Bachelor’s degree in engineering or science, required.


·        Required experience: 3-5 years successful experience in a medical device/biotech industry in process/manufacturing engineering or quality assurance with focus on deviations and nonconforming material control/dispositioning within a manufacturing environment.


·        Working knowledge of ISO 13485 and FDA Quality System Regulations, required.


·        Flexibility to travel (approximately 10% of the time, but as needed)


·        Strong written, computer and verbal skills with an extensive knowledge of the Microsoft Office Applications, especially Excel. SAP experience, strongly preferred.


 


Preferred Knowledge/Skills, Education, and Experience


 


 


·        Mechanical, electrical or biomedical engineering background.


·        ISO Lead auditor certification from a recognized 3rd party.


·        Minitab or Statistical analysis Tools experience.


·        Six Sigma green or black belt certification.


·        Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA).


·        Direct ISO 13485/FDA inspection experience.




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