A global Medical Device company in Irvine, CA is looking to identify and hire an Associate Documentation Specialist who will ensure that appropriate and necessary documentation is in place to meet Quality System in compliance with regulatory requirements.
The Associate Documentation Specialist will be responsible for but not limited to:
- Reviewing change package against governing procedures, interacting with departments to complete the change package, and releasing final change package.
- Performing incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation).
- Participating in special projects, completing assigned tasks and deliverables.
- Evaluating changes proposed by initiators and providing feedback.
Professional Skills & Qualifications:
- Other incidental duties assigned by leadership.
- Bachelor's degree with 2 years of recent relevant experience or 4 years of experience without degree.
- Color vision test required. Near sight vision test required. Must be able to see 20/20 with glasses or contacts.
- Experience with project management and project management software tools preferred.
- Medical device experience highly preferred.
- Flexibility to work overtime or weekends to meet deadline if requested.
- Proficient computer skills in Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet.
- Team-oriented with the ability to work in a dynamic work environment.
- Excellent written and verbal communication skills and strong interpersonal relationship skills.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Bachelor's degree with 2 years of recent relevant experience or 4 years of experience without degree.
Color vision test required. Near sight vision test required. Must be able to see 20/20 with glasses or contacts.
Experience with project management and project management software tools preferred.
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