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Cordis · 1 day ago

Document Control Specialist I

Irvine, CA

Full-time

Onsite

Entry, Mid Level

$59K/yr - $74K/yr

2+ years exp

Cordis, in partnership with Selution, specializes in advanced drug device combination products for coronary and peripheral artery disease. The Document Control Specialist I provides essential administrative support to manage and ensure compliance of controlled documents and quality records, while collaborating with cross-functional teams and participating in audit preparations.

Health CareHealth DiagnosticsMedical

No H1B

Responsibilities

Manage document control and change control processes, ensuring proper document distribution and training assessment

Monitor change orders and associated training assignments to ensure timely completion of training in accordance with the change order implementation plan

Monitor and follow up on change order and periodic document review status to ensure Key Performance Indicator (KPI) goals are met

Provide training and support to PLM users on the change control process

Perform general filing and record keeping for controlled documents and quality records

Assist with document and data reviews as identified on quality master plan to ensure completeness and accuracy

Review and maintain documentation logs and indexes on a regular basis to ensure data integrity

Provide support for audit preparation and participate in document retrieval during audits

Support onboarding processes related to training and document access

Assist in continuous improvement initiatives, including CAPA and procedure updates

Perform other quality-related duties as assigned

Qualification

Document control experienceChange control experienceMedical Device Industry experienceProduct lifecycle management systemsISO 13485 knowledgeFDA 21 CFR Part 820 knowledgeMS Office proficiencySupportive attitudeAccountabilityAttention to detailCommunication skillsInterpersonal skillsOrganizational skillsSelf-motivatedIntegrityCollaboration skills