Leading Global Innovator Seeks Contractor for the Following
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 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 organization 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. Knowledge and experience in the Diagnostics Medical Devices industry highly desirable (Field Actions, Adverse Events, Complaints etc.).
- Experience with documenting Quality and Regulatory Reports.
- Experience with Complaint Databases.
- Experience with Data Analysis using Excel.
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
- Excellent Technical writing, communication and organizational skills necessary.
- Experience with other Microsoft programs (Word, Power Point, Visio) and expertise in Microsoft Project and time management tools.
- Ability to communicate well complex information and data to others.
- Experience in updating Quality procedures.
If this sounds like the perfect fit, apply today!