- Project Management
- FDA Regulations
- Automotive Diagnostics
- Communication Skills
Acara Solutions is looking for Quality Engineer for our Client located in Newark, DE - 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 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 Healthineers procedures and regulations. - Supports and participates in external partners relationships - 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 CLIENT procedures and regulatory requirements. -Responsible to collaborate effectively with other functions supporting Post Market Surveillance activities.
Required Skills / Qualifications:
Minimum of 4 years experience with documenting Quality and Regulatory Reports.
Minimum of 4 years experience with Complaint Databases.
Minimum of 4 years experience in updating Quality procedures.
Minimum of 4 years experience with Data Analysis using Excel.
Minimum of 4 years experience with other Microsoft programs (Word, Power Point, Visio)
Preferred Skills / Qualifications:
Experience in successful deployment and use of Project Management skills.
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.
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 (Field Actions, Adverse Events, Complaints etc.).
Expertise in Microsoft Project and time management tools.
Communicate well complex information and data to others.
English writing and communication skills.
Technical writing, communication and organizational skills necessary.
Key Working Relationships: Primarily intra organizational contacts and external contacts
Upon offer of employment, the individual will be subject to a background check and a drug screen.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.