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%
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.
· 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.