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
- 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!