Job Summary: 

• Support execution of Corrective Actions.
• Support internal/external audits.
• Follow policies and procedures about best documentation practices.
• Provide training for document control processes.
• Enter and maintain item and bill of material data in ERP, PLM, and other electronic systems as assigned.
• Create and maintain documentation such as Standard Operating Procedures, Departmental Procedures, and Work Instructions.
• Create and process change orders as assigned.
• File and archive documents and records.
• Retrieve documents and records from storage promptly
• Adhere to retention/destruction schedule for documents and records.
• Assure compliance of Company operations to all applicable laws, regulations, and standards, good business practices, and company-documented procedures
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Skills on Resume:

• Corrective Actions (Hard Skills)
• Audit Support (Hard Skills)
• Documentation (Hard Skills)
• Training (Soft Skills)
• Data Entry (Hard Skills)
• SOP Creation (Hard Skills)
• Change Orders (Hard Skills)
• Compliance (Hard Skills) 

Job Summary: 

• Support the Configuration Management Team with administrative tasks
• Maintain a repository of documentation packages including design data, build data, and Quality Records.
• Coordinate and communicate with other departments to manage all necessary documents supporting the design and build of the product.
• Work well with large quantities of data and data packages.
• Read Engineering Drawings and interpret BOM structures within the drawings
• Communicate effectively through phone, e-mail, and correspondence, while maintaining a professional manner
• Operate a variety of office equipment to accomplish daily tasks
• Scan and provide copies of all executed batch records and associated documents to customers.
• Assist and complete document requests for both external and internal customers
• Complete general clerical duties.
• Complete responsibilities by the organization’s policies, procedures, and state and federal laws
• Communicate positively and effectively with various departments 
• Ensure compliance with GMPs and applicable SOPs.

Skills on Resume:

• Administrative Support (Soft Skills)
• Documentation Management (Hard Skills)
• Cross-Department Coordination (Soft Skills)
• Data Management (Hard Skills)
• Engineering Drawing Interpretation (Hard Skills)
• Communication (Soft Skills)
• Office Equipment Operation (Hard Skills)
• Compliance (Hard Skills)

Job Summary: 

• Coordinates ISO visits with necessary staff and manages any corrective actions that occur as a result of external inspections.
• Conducts compliance reviews, identifying deficiencies.
• Recommends corrective actions/remediation plans and follows up to ensure compliance.
• Obtains and maintains regulatory certifications and standards (UL, CE, Atex, ISO, etc.).
• Responsible for maintenance, coordination, and management of ISO documentation including Quality Manual and SPI’s, management review processes.
• Responsible for the maintenance and management of the Corrective Action System (CAS)
• Coordinate and maintain Deviation processes and database utilizing standard work.
• Take responsibility for deviation process flow management
• Facilitate Internal Audit process
• Refine and enhance processes by applying CI, SW, and visual tools.
• Create and Execute product conformance documentation.
• Coordinate, prioritize, and release ETO orders through the use of a database and visual controls.
• Monitors production First-Pass-Yield data, supplier scorecards, warranty trends, and other key quality metrics.
• Partner with the Plant Manager, Production Supervision, Sourcing Team, and ITS–America’s Quality Leader to initiate corrective actions for key quality metrics
• In conjunction with the Supplier Quality Engineer, work with outside vendors to develop or improve manufacturing processes for purchased components.

Skills on Resume:

• ISO Coordination (Hard Skills)
• Compliance Reviews (Hard Skills)
• Corrective Action Management (Hard Skills)
• Regulatory Certification Management (Hard Skills)
• Documentation Management (Hard Skills)
• Internal Audit Facilitation (Hard Skills)
• Process Improvement (Hard Skills)
• Quality Metrics Monitoring (Hard Skills) 

Job Summary: 

• Understand and respond accordingly to all safety alerts, warnings, hazards, etc
• Sort through large amounts of documents and work with supervision to validate needs and function
• Use wide format printer and other office equipment often found in an office setting
• Sort documents with an alpha-numeric based number and file documents accordingly
• Keep a record of documents dispersed to individuals and within the document control area
• Audit documents upon request and at monthly to semi-monthly intervals, according to the rate of new document dispersal
• Set up an effective document dispersal system
• Work with an office manager or designated contact to order and keep supplies to maintain and distribute documents
• Set up a document control area to display documents for general use
• Audit incoming and outgoing transmittals to verify they match the documents being transmitted
• Set protocol for documents issued that may be flagged problematic and outside of normal conditions (i.e. multiple drawings)

Skills on Resume:

• Safety Compliance (Soft Skills)
• Document Sorting (Hard Skills)
• Office Equipment Operation (Hard Skills)
• Document Filing (Hard Skills)
• Document Tracking (Hard Skills)
• Document Auditing (Hard Skills)
• Document Dispersal System (Hard Skills)
• Protocol Setting (Soft Skills)