Document Control Specialist

2 weeks ago

Irvine, United States Cordis Full time

Overview:
MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

The **Document Control Specialist** position provides administrative and operational support to Document Control.

This position interacts with multifunctional personnel in the organization, ensuring proper management of controlled documents and quality records.

**Responsibilities**:

- Manages document and change control processes ensuring proper document number assignment, timely review/approval, release, and distribution of controlled documents.
- Maintains training matrix, assign training, and ensure timely completion of training in accordance with the change order implementation plan.
- Performs data entries for part updates according to document change orders.
- Performs general filing and record keeping for controlled documents and quality records.
- Assists with annual document and data review.
- Reviews and maintains documentation log/index on a regular basis to ensure data integrity.
- Assists with HR activities for onboarding process as needed.
- Provides support for audit activities as needed.
- Supports ongoing effort of process improvement activities such as CAPA and/or procedure updates.
- Performs other quality related duties as assigned.

Qualifications:

- College degree preferred.
- 1-3 years of related experience in Medical Device industry desired.

**Competencies & Skills**
- Precise, Rigorous, Detail-Oriented
- Good communication and interpersonal skills.
- Supportive, keen to promote quality through example and continuous support.
- Fluent in English

**Pay / Compensation**
The expected pre-tax pay rate for this position is $20.62-30.93 per hour

Full time position

Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.

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