Overview: This role is responsible for managing the company's document control system in compliance with ISO 9001, ISO 13485, and other relevant standards and regulations. Under minimal supervision, the Document Control Specialist will handle the creation, review, revision, approval, filing, maintenance, and retrieval of documents and records necessary for the Quality Management System (QMS) and various company processes. Effective communication with internal employees and external parties, including auditors, is essential.
Key Responsibilities:
Document and Record Control
Serve as the Document Control Coordinator within the electronic Quality Management System (eQMS) software.
Act as a power user of eQMS, supporting the organization's use of the system.
Draft documents based on input from stakeholders.
Review Document Change Requests (DCRs) to ensure accurate use of software and consistency with company standards.
Collaborate with team members to address discrepancies or errors, revising documents as necessary.
Logs and Master List Maintenance
Maintain all documentation related to CAPA, NCMR, complaints, audits, equipment, calibration, etc., in accordance with company policies.
Update and edit these records as needed or directed by management.
Ensure entries are accurate, complete, and aligned with company standards.
Training Records Maintenance
Act as the Training Coordinator within the eQMS software.
Review completed training records for accuracy and completeness.
Ensure training records are properly filed electronically and maintain training matrices.
Notify functional managers of upcoming training needs.
Equipment Log Management
Track calibration schedules and ensure equipment critical to production, verification, validation, or quality remains calibrated.
Monitor Preventative Maintenance activities and ensure they are completed on schedule.
Manage calibration and maintenance records, providing them as requested.
Non-Conforming Material Reports (NCMR) / Corrective and Preventive Actions (CAPA)
Issue NCMRs for out-of-specification parts, sub-assemblies, and assemblies.
Track the progress of NCMRs, aiming for material disposition and report closure within one week.
Issue CAPAs for systemic issues or complaints.
Monitor CAPA progress, ensuring timely completion without unnecessary delays.
Qualifications:
Minimum high school diploma or GED required; associate's or bachelor's degree preferred.
Prior experience in Document Control; experience in the IVD or medical device industry is preferred.
Experience in manufacturing or engineering is a plus, but not required.
Proficiency in MS Word and Excel.
Experience with Grand Avenue Software is beneficial, but not required.
Strong communication skills.
Ability to build positive relationships across all levels of the organization.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, t
