Document Control Manager

Document Control Manager

This is a full-time on-site role for a Document Control Manager at Sakuu in San Jose.

This position will lead the efforts to implement the “Arena” Document Management System and ensure compliance with company policies and procedures, Document and Change control, as well as international quality system standards of ISO 9001. The candidate will provide leadership to prepare Sakuu for the ISO 9001 certification audit and will coordinate 3rd party product testing for the safety and transportation of Sakuu products.

Responsibilities Include

• Manage the Arena Document Management system and train Sakuu employees to use it
• Oversee the effective documentation and implementation of the quality management system to assure compliance with customer and regulatory requirements and the standards set by corporate policies
• Manage cross-functional preparation of Sakuu Quality System to pass ISO9001 certification
• Manage the activities of the technical documentation function including engineering/manufacturing SOP documentation, drawings, Bills of Materials, parts list specifications, records management, and engineering change orders.
• Review change order submissions for completeness, accuracy, and reference compliance, and process accordingly. Ensure that existing Change Order procedures and Documentation Standards are followed and adhered to.
• Examine documents to verify compliance, completeness, and accuracy of data
• Confer with document originator and approvers to resolve discrepancies and apply required changes to documents
• Work cross-functionally with the Change Order Implementers to evaluate the impact on Bill of Materials (BOM), revisions, linked and reference documents, etc.
• Establish and manage proper document review processes
• Establish RMA (Customer Returns) logging, tracking, and weekly status reporting.
• Release new, change existing, obsolete old, and distribute soft copies of controlled documents to Suppliers and CMs
• Track and report supplier quality to ensure desired levels of performance
• Coordinate necessary plant personnel for internal, customer, and third-party quality system audits. - Maintain a corrective action system to analyze and correct nonconforming conditions and complaints.
• Coordinate regulatory submissions and product approval, assessing the impact of design changes on regulatory status and determining the compliance with essential requirements Desired Skills and Experience:
• Bachelor’s Degree and experience with QMS document control systems
• Minimum of 7 years in a document management role and/or change order environment with experience in a high technology environment.
• Knowledge of Arena Document Management System is required
• Five (5) years of experience working Office Suite programs (i.e. Word, Excel, PowerPoint & Outlook
• Must be detail-oriented to review drawings and/or document revisions
• Excellent written, verbal, and interpersonal communication skills
• Manufacturing environment knowledge including ERP/MRP/Arena and ISO Auditor experience
• Highly organized team player with excellent time management skills.