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Assoc Analyst, Quality Systems


Intellectt INC


Location

Colorado | United States


Job description

Hello I'm Joyce from Intellectt we have an opening for Associate Analyst, Quality Systems role in Southern California, CA. Please find the job details and description below and if interested You can reach me at [email protected] or call me at +1(732) 627-2419

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). 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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