Quality Engineer 4
Business Unit: Laboratory Diagnostics
Requisition Number: 240461
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 50%
The Quality Engineer (QE) 4 will be responsible for providing Supplier Quality Management support to the New Product Development and manufacturing activities, as required. In this role he/she will interface with R&D, Engineering and Operations to ensure products/ components are in accordance with approved specifications. These activities include management of the associated incoming inspection of parts/components and SAP/QM module support.
Additional responsibilities include:
1)Support established production processes, by participating at daily production and weekly quality meetings.
2)Review and approval of non-conformances, ensuring prompt resolution of issues and continuous supply of material/components to production.
3)Root cause analysis and implementation of corrective action for process related concerns. Analyze failure, corrective and preventive action to respond to customer complaints.
4)Conduct audits (internal and at suppliers), including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
5)Initiate, execute, review and approve changes via change control process.
6)Gathering and analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel. Preparation of QA reports.
7)Assist Quality manager in establishing, implementing and maintaining the quality management system.
8)Provide support during audits and visits to assess supplier's capabilities and/or address quality issues
9)Support test method validation and gage R&R studies.
10) Other Supplier Quality related activities as requested by Management
Bachelor’s Degree in Engineering required, with at least 15 years of relevant experience. Experience to include the following:
- Management of supplier quality from suppliers of different commodities. These commodities include: Castings, Machining, Plastics, Stampings, Electro-mechanical, Electrical systems, Assembly processes, etc.
- Knowledge of manufacturing processes like heat treatment, plating, etc.
- Management and qualification of tooling at the supplier's facilities
- Validation of suppliers' processes, as needed.
- Assessment of suppliers' capabilities
- Experience in development of suppliers' capabilities
Strong background in Supplier Quality within the Medical Device Industry preferred.
ISO 13485 Lead auditor certifications are preferred.