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Assoc Analyst, Quality Systems
7 days ago
Role :
Associate Analyst, Quality Systems
Location :
Hybrid Southern California, CA
Duration : 6 Months on W2
Hybrid role (Details not specified; based on the nature of the work that needs to be performed on a given day).
Candidates must be local in Irvine, California.
Details Of The Project
The project involves converting Edwards' quality management system documents into applicable documents for a new spinoff company focused on critical care.
The team will work closely with cross-functional teams to organize and update documentation for the new company.
Skills Looking For
Medical device experience, preferably with ISO 13485.
Program management skills.
Technical writing and communication skills.
Understanding of compliance in the medical device industry.
Proficiency in Microsoft Suite is necessary.
Experience with change management systems like Ignite is a bonus but not mandatory.
Day-to-day responsibilities: Hosting meetings with subject matter experts and stakeholders; Updating and converting quality management system documents; Organizing and managing data related to project requirements; Collaborating with cross-functional teams to ensure project completion.
Education And ExperienceBachelor's Degree or equivalent in in related field of study
Experience in a quality and/or manufacturing environment in the medical device industry required
0 to 2 years of experience; internship experience or related projects in college.
Top 3 Skills
Medical device experience, particularly with ISO 13485.
Program management skills.
Technical writing and communication skills.
Interview Process
One round of panel video interview.
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