Document Control
Job
Actalent
Santa Clara, CA (In Person)
$56,680 Salary, Full-Time
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Job Description
What will you do? Document Control & QMS Support
- Execute document lifecycle processes including creation, review, approval, revision, distribution, and archival in accordance with QMS procedures.
- Ensure accuracy, completeness, and compliance of controlled documents.
- Perform periodic document reviews and follow up with document owners.
- Support maintenance of QMS documentation structure and records. Change Management (ECO/DEV)
- Administer the Engineering Change Order (ECO) process, ensuring timely processing and compliance.
- Review ECO submissions for completeness and route for appropriate approvals.
- Coordinate with cross-functional teams to ensure changes are implemented accurately.
- Maintain alignment between PLM and ERP systems for approved changes. Systems & Data Management
- Serve as a primary user of PLM systems (Agile preferred) for document and part data management.
- Support data integrity and consistency across systems (PLM, ERP, LMS).
- Generate routine reports and metrics (e.g., ECO status, overdue documents, training completion). Training Coordination
- Assign and track training in the Learning Management System (LMS) for new and revised SOP and Work Instructions.
- Monitor training completion and follow up on overdue assignments. Audit & Compliance Support
- Support internal and external audits by providing documentation and records.
- Ensure document control and change records are audit-ready. Continuous Improvement
- Identify process inefficiencies and recommend improvements.
- Participate in continuous improvement initiatives within document control and QMS processes. Collaboration
- Work cross-functionally with Engineering, Manufacturing, Quality, and other stakeholders.
- Provide guidance to document owners and ECO initiators on process requirements.
Experience, Skills, Abilities:
- 1-3 years of experience in document control, change management, or Quality Systems in a regulated environment.
- Working knowledge of QMS principles and standards (ISO 9001 and/or
ISO 13485
preferred).- Experience with PLM systems (Agile preferred) and ERP systems (Intuitive or equivalent), preferred.
- Strong attention to detail and focus on data accuracy and compliance.
- Ability to manage multiple tasks and meet deadlines with minimal supervision.
- Effective written and verbal communication skills.
- Strong organizational and coordination skills.
- Ability to follow established processes and identify when to escalate issues.
- Proficiency in Microsoft Office tools (Word, Excel, Outlook, SharePoint).
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Santa Clara,CA.
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