Supplier Quality Engineer II
Business Unit: Laboratory Diagnostics
Requisition Number: 231353
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 25%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Quality Engineer 2 will be responsible for providing Supplier Quality Management support to manufacturing and New Product Development 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.
9)Support test method validation and gage R&R studies.
10)Create and maintain inspection plans for parts/components using SAP Quality Module (QM).
Bachelor’s Degree in Engineering or equivalent program with at least two years of relevant experience or the equivalent in related work experience.
Strong background in Supplier quality within the Medical Device Industry, preferred.
ISO 13485 Lead auditor certifications are preferred.