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Document Control Specialist

2 months ago

Irvine, California, 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

  • Collegedegreepreferred.
  • 1-3 years of related experience in Medical Device industry desired.

Competencies & Skills

  • Precise,Rigorous,Detail-Oriented
  • Goodcommunicationandinterpersonalskills.
  • 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 $ 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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Job Locations US-CA-Irvine

ID

Category Quality/Regulatory

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact