This position within Nonclinical Safety will support the B+L Surgical and Vision Care Business Units by ensuring that adequate biocompatibility documentation exists for all new and existing medical device products to meet current and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.
Supports MDR work project (technical files): documentation specialist, in compliance to current standards; needs some experience in non-clinical studies or education – understand the science and update the documents
- Must be in Rochester, NY to support MDR
This position is responsible for effective resolution of consumer inquiries and complaints and for the receipt, documentation, classification, and processing of product complaints within regulatory guidelines, for North America.
The Plant Maintenance team provides electro-mechanical support for production machines and equipment. The team is dedicated to keeping production moving with minimal downtime by troubleshooting and repairing equipment issues. This includes resolving mechanical and electrical problems and performing scheduled maintenance on equipment. This position entails working as a member of a team to perform and document troubleshooting, repairs, and preventative maintenance of high speed manufacturing, injection molding, packaging, and sterilizing equipment. Other aspects may include project work, offline rebuild work as well as training other technicians.
Assists Production Supervisor in carrying out the day-to-day operation and guidance of production personnel involved in manufacturing of product for the facility. Helps maintain general control to ensure compliance with domestic FDA/GMP and all international regulatory requirements. Assists Supervisor in ensuring compliance is maintained in the area concerning environmental, health and safety practices. Trains, facilitates and oversees manufacturing associates to accomplish established work objectives.
This position is a 6:00 pm - 6:00 am C Shift
Assists Production Supervisor in carrying out the day-to-day operation and supervision of production personnel involved in manufacturing of product for the facility.
Helps maintain general control to ensure compliance with domestic FDA/GMP and all international regulatory requirements.
Trains, directs and oversees manufacturing associates to accomplish established objectives.