Administrative Skills, Meeting Minutes, Quality Management, Control Systems, Corporate Policies, Data Collection, Data Recovery, Document Control, External Audit, ISO (International Organization for Standardization), Internal Audit, Product Documentation, Validation Plan,
- High School Graduate or GED required. Associates (2 year college or technical school) or Bachelor’s Degree (4 year college or technical school) preferred in a related field, or relevant experience in document control / auditing.
- 1-3 years experience in document control specialization including experience with internal and external audits. Experience working with MasterControl a plus.
- Proficiency in Microsoft Office Suite and using document control based systems.
- Responsible for the document control management system (Master Control) and become the expert in its operation, continually finding ways to improve use of it’s functions and efficiencies across the organization.
- Launch and maintain change control for documents; process and track all changes assuring a standard format of new and revised documents is maintained.
- Responsible for the initiation of training for new and revised documents and then distributing / maintaining the department reference binders for master policies, procedures, forms where applicable.
- Coordinate periodic review of procedures and forms. Maintain the archives and historical files for mastered documents and records.
- Support the maintenance of the training database, training records, historical files on training programs and signature files.
- Set up users in the data management system and provide training to new hires on how to use the system effectively.
- Ensure that proper procedures are being followed in making database changes, additions and deletions.
- Be a quality auditor for compliance and audit execution.
- Coordinate and manage ISO9001, ISO14001, and customer audits, including but not limited to preparing audit documentation/reports, scheduling audits with auditors (internal and external), communicating pre-audit or closing audit items to stakeholders, participation in audits, providing additional support to Quality Engineers in the audit process.
- Stays up to date on auditing standards and regulations as well as company policies and procedures to ensure accurate and compliant audits.
- Perform other job-related duties as assigned.
Paid Time-Off, Gym Membership, Life Insurance, Tuition Reimbursement, 401K, Prescription Drug Coverage, 401K Match, Paid Sick Days, Parking, Professional Development, Flexible Spending Accounts, Medical, Dental, Vision
The QMS Administrative Assistant is responsible for administrative management of the Quality Management System (QMS) system and document control system. Works closely with the manager, department engineers and assists in all company audits (internal and external). This includes but is not limited to scheduling, setting audit agendas, data collection and retrieval, and being present and participating in all audits. Responsible for the companies document control management system (Master Control) and assures relevant documents used at Fujimi Corporation are deployed into the document control management system per company policy. Includes assessing and processing product related documentation, drawings, department process flowcharts, procedures, product/process specifications, external standards, validation protocols and work instructions as used by the business. Will be the key point of contact for items related to the organizations QMS/EHS related ISO, customer and other audits.