Quality Document Control
52 Discovery Irvine, CA 92618 US
Job Description
Quality Document Control is responsible for:
Prepares medical device reports, generates customer letters, and ensures completeness and consistency of the documentation for complaints.
Duties & Responsibilities:
- Evaluate documentation for completeness and consistency and assign additional actions as necessary to close complaint.
- Ensure all required medical device reports are submitted in accordance with Company procedures.
- Perform initial evaluation of complaints for reporting in accordance with regulations and Company procedures.
- Drafts and review customer responses and or responses to regulatory bodies;
- Ensure that all complaints requiring customer responses are properly addressed, as assigned.
- Perform other duties or special projects assigned.
- Two to three years’ experience working in a document control environment.
- Familiarity with medical device complaint files and quality records.
- Skills required:
- Strong computer skills
- Ability to interact effectively on a team and with internal and external customers
- Demonstrated written and verbal communication skills
- Demonstrated independent worker with ability to focus
- Demonstrated attention to detail Preferred Qualifications:
- Clinical experience/background is preferred
Education:
High School Diploma or GED is required.
Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.