Terrific Contract Opportunity!

Our client is one of the world's largest producers of energy-efficient, resource-saving technologies. Come be a part of how digitalization, globalization, urbanization, demographic change, and climate change are transforming our world.

Position: Quality Engineer

Location: Newark Delaware 19702

Term: 5 Months

Day-to-Day Responsibilities:

• Review, approve Quality Technical Documentation related to Post Market Surveillance Reports and plans.
• Track project performance, specifically to analyze the successful completion of short- and long-term goals.
• Performs project/program management activities (defining scheduling, risk, change and opportunity and resources activities).
• Support the CPQ Post Market Surveillance Lead to ensure schedule compliance.
• Participates in technical review of Project related processes and documentation.
• Independently performs important areas of standard professional level work that typically requires processing and interpreting more complex, less clearly-defined issues.
• Schedules and may lead meetings to coordinate cross functional project activities required to resolve project issues.
• Supports project communications to all stakeholders including meeting minutes, monthly updates and other communications.
• Monitor status of each Post Market Surveillance Team deliverable; follow up effectively on each deliverable to ensure compliance to schedule and applicable Siemens Healthineers procedures and regulations.
• Supports and participates in external partners relationships where required.
• Report to Post Market Surveillance Lead any discrepancies or issues that would place the project at risk.
• Create tools to manage efficiently assigned Projects.
• Support in updating / creating procedures.
• Support in trending and reporting requirements as they relate to Adverse Events and Field Actions.
• Serve as a backup for Complaint Searches in the Complaint Database.
• Create Customer Lists to Support the Field Action Process. May be assigned to other Commercial Product Quality activities.
• Write professional reports and presentations for reporting to management.
• Ensure documents are complete and in compliance with Siemens procedures and regulatory requirements.
• Responsible to collaborate effectively with other functions supporting Post Market Surveillance activities.

Is this a good fit? (Requirements):

• Experience in successful deployment and use of Project Management skills.
• Ability to work and influence in a matrixed organization is essential
• Knowledge of FDA Medical Device Regulations such other worldwide laws and regulations.
• Expertise and ability to use a variety of electronic (IT) systems to facilitate efficient project management.
• Requires skills in the Post Market product processes and a general business understanding, preferably in the medical device industry (FDA 820, 803, 806) or pharma.
• Experience with documenting Quality and Regulatory Reports.
• Experience with Complaint Databases.
• Experience with Data Analysis using Excel.
• Experience with other Microsoft programs (Word, Power Point, Visio) and expertise in Microsoft Project and time management tools.

Even better if you have:

• Knowledge and experience in the Diagnostics Medical Devices industry highly desirable (Field Actions, Adverse Events, Complaints etc.).

If this sounds like the perfect fit, apply today!