Back to Job Search

Quality Engineer

  • Location: Newark, Delaware, 19702
  • Job Type:Contract

Posted 20 days ago

  • Function: Telecom
  • Job Ref: 184986

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!