Quality Engineer 4
Business Unit: Laboratory Diagnostics
Requisition Number: 235478
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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.
Quality Engineer, New Instrument Quality Lead, based at our Flanders Instrument Manufacturing site in New Jersey. The Flanders facility has undergone significant expansion in the last 2 years. This role will drive the site quality organization to prepare for the manufacture of our next generation of instrument.
Summary of the position.
- Manage all quality activities related to the launch in manufacturing of the next generation of instrument.
- Reports into the Director of Engineering, New Instrument Manufacturing Site Lead
- Designs and leads training on QMSTs.
- Designs sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data.
- Leads economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Designs, leads, and provides guidance to multiple operations for QMST. Designs and lead standards and methods for inspection, testing, and evaluation. Independently performs leading-edge areas of work for the professional field. Preempts potential problems and provides effective solutions in reaction to application of concepts, techniques, knowledge, or processes.
- Displays original thinking in applying principles, theories, and concepts on a wide range of problems.
· As key member of the site New Instrument Manufacturing Team, represents the Quality functions (Internal Quality and Supplier Quality)
· Collaborate with Procurement and Engineering in supplier selection
· Develop New Instrument Quality Plan
· Interface with R&D, Engineering, Procurement and Operations to ensure products/ components are in accordance with specifications
· Manage the incoming inspection of prototype parts/components (800+ new parts)
· Review and approval of non-conformances, ensuring prompt resolution of issues and continuous supply of material/components to production
· Drive sourcing activity for components of instrument prototypes
· Manage quality readiness for commercial ramp up of instrument manufacturing
· Communicate quality readiness for instrument launch
· Collaborate with related business partners
Required Knowledge/Skills, Education, and Experience
· BS/BA in
related discipline, or advanced degree, where required, or equivalent
combination of education and experience.
Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues.
8-10 years of successful experience in related field.
Preferred Knowledge/Skills, Education, and Experience
- Strong background in quality within the Medical Device Industry, a plus
- Lean Manufacturing or Six Sigma Certification, a plus
- Project Management Certification, a plus