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Newark, DE 19725
Req Ref No: MDD2EQE2-90
Location: Newark, DE
Duration: 5.0 months
Quality Engineer is responsible for facilitating the efficient execution of all assigned Quality Compliance project activities and also will support the Commercial Product Quality (CPQ) in reviewing and updating Field Action, Adverse Events and other LD Post Market Surveillance Procedures.
The Quality Engineer is responsible for supporting the client teams in the planning, scheduling, tracking, coordination, monitoring, and successful completion of Regulatory projects to fully comply with Food and Drug Administration (FDA) regulations, IVDR (In Vitro Diagnostics Medical Device Regulation) and all applicable other external regulations and laws.
In addition this position will support in trending and reporting requirements as they relate to Adverse Events and Field Actions.
The Quality Engineer 3 will be fully engaged in the Support of the creation, review and approval of Quality Technical Documentation to comply with Regulatory Requirements with ability to summarize and interpret quality data such as Field Actions, Adverse Events, Complaints and other data. It is important that it is understood that this is a Non Manufacturing support, Non Medical Device Design Support, Non Process Validation activities support.
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 client 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 the client procedures and regulatory requirements.
Responsible to collaborate effectively with other functions supporting Post Market Surveillance activities.
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 client 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.
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.
Excellent English writing and communication skills.
Experience in updating Quality procedures.
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.
Key Working Relationships: Primarily intra organizational contacts and external contacts
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.