- The candidate will support Quality with primary responsibility for the hands-on management of documentation supporting in vitro diagnostics (IVD) product on-market product improvements and changes, specifically for key accounts.
- This candidate will work closely with cross-functional teams to edit, review and finalize technical documents required for IVD products which includes but not limited to documents involving procedures, specifications, change control, and other documents associated with support of existing products in the field.
- The candidate will review project documentation, assess necessary resources, and estimate timelines for documentation development and review.
- Knowledge of US and European medical device documentation and associated regulatory requirements would be an advantage.
Major Tasks and Responsibilities:
- Coordinating with internal and external experts to organize and maintain documentation pertaining to the development, manufacture, and life cycle of IVD products.
- Writing, analyzing, and editing design control documents, SOPs, validation documents, manufacturing and testing documents, and other documents.
- Collaborates with cross-functional teams to support successful completion of change implementation and product sustaining projects.
- Representing the technical writing viewpoint within cross-functional meetings.
- Perform other responsibilities to support the needs of the department as assigned.
- B.S. in a relevant scientific field, such as biochemistry, molecular biology, Quality, Engineering, or cell biology.
- At least 2 years of technical writing experience, preferably in the IVD field and with experience in writing project documents and change control.
- Experience with drafting, reviewing, editing verification/validation protocols and reports.
- Knowledge of quality and regulatory compliance for development of medical device products.
- Experience with MasterControl, Agile, or other Document Control platforms is desirable.