Quality Engineer 4
Business Unit: Laboratory Diagnostics
Requisition Number: 233677
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.
Designs and leads training on Quality Management System Topics. 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.
BS in Engineering or Science field . Must be able to analyze
Quality Data and have strong excel capabilities. Lead Auditor Certification
preferred, Certified Quality Engineer/Auditor, Prefferred. Six Sigma Gren belt
or high certification, highly preferred. may be required in some areas.
Demonstrates and applies comprehensive knowledge of the quality system regualtions, ISO 13485:2016 and its requirements. . Demonstrates advanced knowledge of concepts, practices, and procedures for Nonconforming Material, Statistictal Techniques, Advanced problem solving and CAPA. Demonstrates significant knowledge of
organization's business practices and issues faced and contributes to problem resolution of those issues.
Typically 8-10 years of successful experience in Quality and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
Acts as advisor to top management and business partners on
advanced technical matters.
Represents the company as the primary external contact.
Develops team members through mentoring and coaching in complex subjects.