Quality Systems Analyst - Charleston, United States - INTELLECTT INC

INTELLECTT INC Charleston, United States

3 weeks ago

Description

Role :
Assoc Analyst, Quality Systems

Location :
Hybrid Southern California

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).

If there are meetings or training they can do it remotely.
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.

There will be approximately 38 different projects corresponding to different quality management system streams.
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 Experience

Bachelor'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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