Siemens Careers

Quality Engineer 1

Hoffman Estates, Illinois
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 224712
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Entry level
Education Required Level: Bachelor's Degree
Travel Required: 25%

Division Description:

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare




Job Description:

Position Summary

Siemens Healthineers currently has an exciting opening for a Quality Engineer I. This role is responsible for all aspects of Post Market Surveillance for Molecular Imaging medical devices. Previous experience as a Nuclear Medicine Technologist or in a role with medical device complaint handling preferred.

 

Responsibilities

Responsible for Post Market Surveillance compliance activities to include: complaint handling, complaint trending, post market data review and trending, adverse event reporting, recall reporting. Support for product licensing (data and trending).

·        Compile data (CS service tickets, HSC tickets and complaints), identifies trends, and prepare periodic Quality Systems Management Reviews (with proposed action items) for Senior and Executive Quality and Operations management

·        Identifying trends and proposing CAPAs

·        Provide periodic reports on KPIs and the status of open investigations

·        Process and manage complaint files

·        Submit adverse event and vigilance reports

·        Submit recall reports

·        Support for post market surveillance data mining, review, trending and reporting

·        Support as subject matter expert during inspections and audits

·        Lead and implement multiple continuous projects

 

Required Education/Skills/Experience

·        Bachelor’s degree in related discipline

·        Capable of processing complaints thoroughly and efficiently with attention to detail

·        Strong organizational skills and ability to multitask

·        Capable of performing technical and administrative tasks required by the role

 

Preferred Education/Skills/Experience

·        1-3 years of experience in a RAQA function or experience with nuclear medicine or clinical environment

·        Direct experience handling complaints in the medical device industry

·        Experience participating in FDA inspection

·        Adverse Event reporting experience


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