Process Lead- EUMDR job vacancy

Vacancy expired!

Process Lead: The Labeling Process Lead II will be accountable for identification and development and revisions to surgical labeling (including IFUs, Manuals, Cartons, and product identification labels). This position will serve as a point person for project teams, working with stakeholders to gather requirements, create and manage complex label change projects.

Process Lead

Main areas of responsibility:

Responsible for developing change control documentation and design changes related to labeling including labels, packaging and BOM changes
Manage multiple project priorities with internal and external customers
Proofing of digital and printed content
Deliver status updates and communicate progress to key stakeholders
Ensure processes and standards are upheld when executing changes
Accountable for maintaining label design and process knowledge for assigned platform
Support label CAPAs and non-conformances as needed
Outsource or perform graphics label revisions and changes as required

Skill set/experience preferences:

MDM experience - Plus
MDR - Plus
Understanding of labeling and steps to release and implement - must
UDI/GUDID - Plus
Translation process experience - Plus
GA/Tech Writer experience & knowledge of solutions (ACS, FrameMaker, & Easy Label) - Plus
(Change management) PLM experience - Agile/Windchill - Plus
GS1 bar code standards - Plus
Excellent Communication skills - Must have
PM experience - Plus

Digital Intelligence Systems, LLC (DISYS) is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

ID: #49573811
State: California Irvine 92616 Irvine USA
City: Irvine
Salary: USD TBD TBD
Job type: Contract
Showed: 2023-03-28
Deadline: 2023-05-26
Category: Et cetera