Siemens Quality Engineer 2 in Flanders, New Jersey
Quality Engineer 2
Locations:Flanders, New Jersey
Job Family: Quality Management
Division: Siemens Healthineers
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 aboutenabling healthcare professionals to deliver high quality patient care, and todo so affordably. A leading global healthcare company, SiemensHealthineers continues to strengthen our portfolio of medical imaging andlaboratory diagnostics, while adding new offerings such as managed services,consulting, and healthcare IT services – as well as further technologies in thegrowing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that supportbetter patient outcomes with greater efficiencies, giving providers theconfidence they need to meet the clinical, operational and financial challengesof 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.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .