Quality Engineer II
Business Unit: Healthineers (HC)
Requisition Number: 234282
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Mid 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.
This Quality Engineer will work as a member of the Northern Indiana manufacturing operations facility Quality Team where reagents for the Siemens CLINITEK Atlas® Automated Urine Chemistry Analyzer and DCA Vantage® Diabetes Analyzer are currently manufactured.
The purpose of this position is to support all quality system processes, responsible for developing and facilitating process improvement activities, chairing the CAPA review board, and coordinating the site internal audit program. The successful candidate will drive key performance indicators and analyze quality trend data to identify and implement improvements.
Major Job Responsibilities
· Responsible for Corrective and Preventive Action (CAPA) program. CARB Chair. Initiate and lead root cause and corrective action activities for site.
· Initiate and facilitate quality improvement activities with the respective process owners within their operations.
· Responsible for coordinating Internal Audit Program.
· Drive quality Key Performance Indicators (KPIs) metrics and report results to management.
· Provides training on Quality concepts and improvement tools
· Develop and improve process flows, procedures, forms and instructions to help streamline working practice.
· Analyzing production and quality trend data to identify and solve problems.
Required Knowledge/Skills, Education, and Experience
· BS/BA in science related discipline, or equivalent combination of education and experience.
· Typically 2-5 years of successful experience in quality processes and quality systems management.
· Demonstrated ability to lead cross functional team projects.
· Strong troubleshooting skills.
· Solid interpersonal and collaboration skills.
· Experience with CAPA and RCA tools.
· Experience with Internal Audit coordination for medical device industry.
· Experience in SAP, Documentum, Learn4U, and CATSWeb preferred.
· 2-5 years of experience in medical device manufacturing facility and successful demonstration of meeting key responsibilities.
· Advanced knowledge of FDA and ISO 13485 Quality Management Systems and have applied them to the workforce.
· Competent with Microsoft Office suite (Excel, Word, Outlook, etc.)
· Background in LEAN manufacturing principles
Job Family Responsibilities:
Analyze quality trend data to identify and solve problems. Design and develop systems for recording, evaluating, and reporting quality data.
Knowledge and Experience:
Demonstrate successful completion of complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrate knowledge of organization's business practices and issues.
Key Working Relationships:
Primarily intra-organizational contacts and external contacts.