Newark, United States
over 1 year ago
The Quality Analyst 3 will be responsible to support in the creation and maintenance of Quality System documentation and records related to Field Actions, Adverse Event Reporting, Product Quality and others to support various regulatory requirements (Food and Drugs Administration (FDA), IVDR (In Vitro Diagnostics Medical Device Regulation) and other external regulations and laws. Support Siemens Healthineers Laboratory Diagnostics (LD) Commercial Product Quality (CPQ) in updating and creating procedures, processes records and guidances that are fully compliant with all applicable regulations for LD post market activities. Carries out complex to semi-complex Medical Devices and In Vitro Medical Device regulations compliance assignments while ensuring assigned Projects are on schedule. Participates in the implementation of procedures, presentations and training to various functional groups in the Quality and Technology LD Business Area and other groups. Identifies and resolves issues by applying problem solving skills. Displays effective use and application of the Quality and Compliance concepts to successfully generate and analyze quality data from internal and external sources. Demonstrate knowledge of LD organization's business practices and procedures and demonstrate knowledge of the quality function through successful completion of assignments. Experience in Quality Systems, Medical Device Adverse Event Reporting, Field Actions, Document Controls and Product Quality Issues. Collaborate and communicate effectively cross functionally to review and assess LD CPQ assigned projects and tasks are executed in compliance with schedules and Siemens Healthineers procedures and external regulations.
- Create tools and spreadsheets to manage efficiently and effectively large amount of data.
- Support in updating / creating Quality System procedures.
- Ensure assigned Medical Device and In Vitro Projects for Post Market Surveillance are on schedule and processes are compliant to all applicable requirements
- Write and edit Quality and Regulatory reports and ensure proper data analysis is conducted.
- Ensure documents are complete and in compliance with Siemens procedures and regulatory requirements.
- Responsible to collaborate effectively with other functions.
- Review internal documentation from the complaint system, Field Action, CAPA, Adverse Events Reports other records.
- Conduct searches in external quality databases and conduct analysis, reporting and documentation
- Support in creating process for EUDAMED reporting.
- Experience with FDA Regulations such as 820, 803, 806, MEDDEV, IVDR published on 5 May 2017 in the Official Journal of the European Union and other medical device laws and In Vitro Medical Device regulations.
- Knowledge of Quality System audits and Risk Management processes.
- Ability to use a variety of electronic (IT) systems to facilitate efficient data analysis and reporting.
- Knowledge of complaint systems, Adverse events reporting and Field Actions.
- Experience searching in the FDA MAUDE database, FDA Recall database, BfArM database and other worldwide databases.
- Knowledge and Experience in Documenting Regulatory Reports.
- Data Analysis using Excel and other data management tools, knowledge of other Microsoft programs (Word, Power Point, Visio).
- Create solutions to manage efficiently and effectively large amounts of data.
- Ability to communicate well complex information and data to others.
- Excellent English writing and communication skills.
- Experience in updating Quality procedures.
Education: 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.
5-8 years experience