Quality Engineer 2

Flanders, New Jersey, United States
10 May 2018
18 Jun 2018
Contract Type
Full Time
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 224363
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%

Division Description:

Siemens is a global technology powerhouse that\nhas stood for engineering excellence, innovation, quality, reliability and\ninternationality for more than 165 years. As a global technology company,\nSiemens is rigorously leveraging the advantages that this setup provides. To\ntap business opportunities in both new and established markets, the Company is\norganized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy\nManagement, Building Technologies, Mobility, Digital Factory, Process\nIndustries and Drives, Healthineers and Financial Services.
\n With 45,000 employees Siemens\nHealthineers is one of the world's largest suppliers of technology to the\nhealthcare industry and a leader in medical imaging, laboratory diagnostics and\nhealthcare IT. All supported by a comprehensive portfolio of clinical\nconsulting, training, and services available across the globe and tailored to\ncustomers' needs. So that more people can have a life that is longer, richer,\nand more filled with happiness.
\n For more information, please visit: http://www.usa.siemens.com/healthineers

Job Description:

Position Overview
\n The Quality Engineer 2 will be responsible to support the manufacturing change management process by coordinating the changes to be presented, providing guidance to change leaders for change documentation, reviewing change documentation for completeness, circulating documents for approval, and filing completed documentation. This position will also assist in extracting and organizing data for the change process and making improvements to the process.
\n This position requires the following skills:
  • \n Knowledge of change management processes; including relationship with process validation and process risk, nonconformance and CAPA
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  • \n Ability to communicate well with others and provide guidance to others both written and orally
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  • \n Attention to detail and organization
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  • \n Use of Microsoft Office (Outlook, Excel, Word, PowerPoint)
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  • \n Ability to organize data to evaluate for trends
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  • \n Knowledge of FDA 21 CFR Part 820 and ISO 13485
\n Responsibilities
\n Attends Change Review Board (CRB) meetings and actively provides feedback on changes being presented. Provides guidance to change leaders prior to presentation at CRB to ensure compliance to change management process. Runs change review board meetings in absence of CRB Chairperson. Supports process improvement initiatives in change management. Manages change documentation.
\n Additional responsibilities include but are not limited to:
  • \n Support operations by attending daily production meetings
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  • \n Participate in internal audits and external audits
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  • \n Participate in CAPA root cause investigations associated with change process
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  • \n Compiles data for change management in preparation of management reviews
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  • \n Support process validation review by providing validation guidance
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  • \n Support nonconformance process by performing investigations, when necessary
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  • \n Participate in value stream mapping and kaizen events for change management and process validation
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  • \n Writing procedures or creating forms/templates for use
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  • \n Support risk analysis process by reviewing pFMEAs
\n Required Knowledge/Skills, Education, and Experience
\n Knowledge of quality system requirements specific to medical device or pharmaceutical manufacturing. Understanding of process improvement techniques and
  • BA/BS in related discipline (Engineering or Life Sciences preferred)
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  • 2-5 years experience in medical device manufacturing environment
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  • Experience with change management processes (design or process changes)
\n Preferred Knowledge/Skills, Education, and Experience
\n Preferred knowledge of process validation requirements, process risk analysis (pFMEA), nonconformance process and CAPA.


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