Siemens Careers
Quality Engineer 3
Job Description
Business Unit: Diagnostic Imaging
Requisition Number: 237786
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
Division Description:
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.
Job Description:
Position Overview
Participates in formulating quality programs, plans, procedures
and practices. Performs semi-complex statistical analysis as related to product
and material quality. Supports in the analysis of defective material and leads
in the final disposition of defective material through the material review
board process. Analyze production and material review board data to determine
trends to initiate corrective action and identify continuous improvement
opportunities. Conducts semi-complex audits of supplier quality system or
manufacturing processes to determine compliance with our quality requirements.
Provides monthly performance input to the supplier rating system. Provides input
during new supplier evaluation to determine suitability for inclusion to the
Approved Supplier List ( ASL). Maintains the required views in the SAP ERP
system including inspection planning. Provides technical in-put, training and
guidance to inspectors.
Responsibilities
Primary
responsibilities include the approval, development and management of all direct
and indirect quality relevant material suppliers, and to ensure the material
received from them is conforming.
Work
cross-functionally in support of product development to ensure that that the
supply chain is fully qualified before product release.
Review
design specifications and develop material inspection plans within the SAP ERP
system to be used incoming inspection personnel to assess the conformance of
received material. Provide assistance
and guidance to inspection personnel as needed.
Develop
and maintain supplier performance KPI’s and utilize them assess quality trends,
performance target setting and verify effectiveness of implemented corrective
action plans.
Analyze
the complexities and interrelationships of non-conforming material situations
and determine the root cause as well what an effective corrective action plan
would entail. Evaluate 8D responses from suppliers to formal corrective action
requests (SCARs) for thoroughness and effectiveness.
Proficiently
use of basic statistical analysis methods and practices to analyze processes
and corrective action plans to determine the state of control or effectiveness.
Conduct
on site supplier QMS and or process audits and drive corrective action plans
Excellent
decision making abilities showing awareness of risk and regulatory
requirements. Able to evaluate options and solutions while using good judgment.
Required Knowledge/Skills, Education,
and Experience
Must
have an accumulated 5 to 10 years of successful experience in quality
disciplines or related field, and successful demonstration of key
responsibilities and job knowledge. Must
have a BS degree in a technical field, ME, EE, or IE preferred.
Preferred Knowledge/Skills,
Education, and Experience
Experienced in performing both quality system and product audits
performed at a supplier or subcontractor facility both domestic and
internationally. Have obtained
sufficient audit training from an accredited source (ASQ or ANSI-RAB NAP)
resulting in an ASQ-CQA or RAB certification.
Achieved and maintained ASQ-CQE certification
Knowledge
/ training of ISO 13485 and ISO 9000
Received
training and successfully implemented quality assurance methodology to analyze
and control key process parameters (Six Sigma, SPC, gage R&R, FMEA, and
Poke –Yoke, etc.)
Proficient
with Microsoft Office with emphasis on EXCEL.
Minitab experience would be a plus.