Job Description :
5+ years of experience in medical device or pharmaceutical fluid fabrication and packaging, LVP solution experience preferred
medical device or pharmaceutical fluid fabrication and packaging a plus.
FDA experience in medical device and parenteral drug industry preferred
Intermediate knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2003, Canadian MDR, Medical Device Directive, and ISO14791.
Strong analytical skills, excellent verbal communication and customer interface skills
Ability to interface with multiple groups in the organization.
Intermediate/advanced computer skills – word processing, spreadsheet, Windows, MS Office