Medical Device Jobs in Edison (NJ)
Responsibilities:
This position is responsible for the preparation of regulatory submissions required to market medicaldevices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities...
as well as supporting departments
Responsible for the handling, performance of visual and functional inspection of all tooling, decontamination, sterilization, and documentation for the medicaldevice kits for field surgeries. Possible exposure...
Location: Irvine, CA (Day 1 onsite)
Duration: Fulltime
Job Description:
Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), MedicalDevice Directive (MDD...
Overview/Risks:
The Process Technician is responsible for aseptically processing human cells, tissues, and cellular and tissue-based products for transplant in a controlled and regulated medicaldevice environment. This position requires...
Knowledge and experience in Pharma and/or MedicalDevice Manufacturing related operational transformation
Executed Digital Transformation strategies in Manufacturing or Quality domains incl experience in Applications (like MES, CMMS, QMS...
as well as supporting departments
Responsible for the handling, performance of visual and functional inspection of all tooling, decontamination, sterilization, and documentation for the medicaldevice kits for field surgeries. Possible exposure...
Dimensioning &Tolerancing)
" Knowledge and experience in product development processes and
design control is preferred.
" Experience with statistical analysis and design of experiments (DOE)
preferred.
" In-depth knowledge of design of medicaldevices...
Overview/Risks:
The Processing Supervisor is responsible for directing all activities related to Processing in a controlled and regulated medicaldevice environment. This position requires the Supervisor to work closely with Management and Team...
Overview/Risks:
The Process Technician is responsible for aseptically processing human cells, tissues, and cellular and tissue-based products for transplant in a controlled and regulated medicaldevice environment. This position requires...
- Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medicaldevice regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws...
School Diploma/GED
Years of Experience: 1 year Experience in one of the following: tissue banking, surgical technician, nursing or relatedmedical technology background, medicaldevice or pharmaceutical manufacturing, ISOclean 8 or less cleanroom...