Document Control Specialist II

Job Description:

The Document Control Specialist II is responsible for maintaining control of all quality documentation. This position works independently, with minimal supervision, in accomplishing daily tasks and advising others. The role requires close collaboration with all departments to maintain a compliant program.

This position organizes, maintains, and updates all controlled documents. All functions of the document center must be in compliance with quality system GMP, 21 CFR 820 (FDA), ISO 13485, and other quality standards.

The Document Control Specialist II leads projects with minimal support within established deadlines and expectations.

Key Responsibilities:

• Process, release, and control Engineering Change Orders
• Create part numbers and Bill of Materials (BOMs) in the ERP system
• Process, maintain, and monitor deviations
• Process, release, and control all Quality documents (e.g., Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle of product documentation
• Manage the calibration of all calibrated equipment and ensure it is within specification and certification
• Support the Head of Quality to establish and maintain Quality Systems in a compliant manner
• Interact with manufacturing, design engineering, quality regulatory, marketing, customer service, and management
• Write, create, update, and submit Quality SOPs, Forms, Templates, and other Quality documents for review and approval
• Lead Document Control Quality projects and drive them to completion within established deadlines
• Identify continuous improvements in Document Control processes and drive their implementation

Essential Duties:

1. Promote a work environment of continuous improvement that supports CIVCO Radiotherapy's Quality Policy, Quality System, and relevant regulations
2. Assist with communicating business-related issues or opportunities for improvement to management
3. Accountable for document control compliance with applicable US and International regulations and directives
4. Assist with creating, editing, and proofreading documents
5. Maintain Document Control systems
6. Archive obsolete and historical documents
7. Create and maintain part numbers and Bill of Materials in ERP/MRP systems
8. Monitor training history documentation
9. Work in a team environment to achieve metrics and business goals
10. Collaborate with engineering and other stakeholders to process Engineering Change Orders in a timely manner
11. Key stakeholders include but are not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer Service, and Manufacturing
12. Lead and maintain the Layered Process Audit program
13. Lead Quality Projects related to Document Control and drive them to completion
14. Support management review and all audits/inspections
15. Maintenance of Quality procedures
16. Administration of the Calibration program
17. Assist with CAPAs related to Document Control
18. Assist with internal audit program
19. ISO 13485:2016 & EU-MDR 2017/45 Lead Internal Auditor
20. Drive Continuous Improvement projects
21. Write, create, update, and submit Quality SOPs, Forms, Templates, and other Quality documents for review and approval
22. Remain current on all required training
23. All other job functions as assigned

Working Conditions:

• <40 lbs. of lifting required for this role
• <10% of this role is spent traveling
• Hearing protection, safety glasses, safety shoes, gloves are required for this role
• Required exposure to biohazard

Qualifications:

• Very strong proofreading and organizational skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents
• Strong problem-solving skills
• Strong written communication skills required
• Ability to interact with individuals and groups at all levels
• Decision-making ability
• Ability to identify priorities and function independently required
• Must be able to manage multiple tasks performed with accuracy and high attention to detail
• MS Office Suite (Word, PowerPoint, and Excel) experience required

Education and/or Experience:

• Bachelor's degree is required
• Experience in a manufacturing environment, preferably in medical devices, is beneficial
• Requires three to five years' experience in a Quality Management System, preferably medical devices