About the role
The Document Control Specialist II maintains control of all quality documentation. This position works independently, with minimal supervision, in accomplishing daily tasks and advising others. This position works closely with all departments to maintain a compliant program. This position is responsible for organizing, maintaining, and updating 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. This position actively and independently leads projects with minimal support within established deadlines and expectations.
The Document Control Specialist II:
* Processes, releases, and Controls Engineering Change Orders.
* Responsible for creating part numbers and Bill of Materials (BOMs) in the ERP system.
* Processes, maintains, and monitors deviations
* Processes, releases, and Controls all Quality documents (e.g. Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle of product documentation.
* Manages the calibration of all calibrated equipment and ensures all calibrated equipment is within specification and certification, as required, is maintained.
* Supports the Head of Quality to establish and maintain Quality Systems in a compliant manner.
* Interacts with manufacturing and design engineering, quality regulatory, marketing, customer service, and management.
* Writes, creates, updates, and submits Quality SOPs, Forms, Templates and other Quality documents for review and approval.
* Leads Document Control Quality projects and drives the projects to completion within established deadlines.
* Identifies continuous improvements in Document Control processes and drives and implements those improvements.
Essential Duties:
1. Promotes a work environment of continuous improvement that supports CQ Medical's Quality Policy, Quality System, and the appropriate regulations.
2. Assists 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 including, but not limited to, Food & Drug Administration (FDA), Canadian, and EU MDR regulations.
4. Assists with creating, editing, and proofreading documents.
5. Maintains Document Control systems.
6. Archives obsolete and historical documents
7. Creates and maintains part numbers and Bill of Materials in ERP/MRP system
8. Monitors training history documentation
9. Works in a team environment to achieve metrics and business goals.
10. Collaborates with engineering and other stakeholders to process Engineering Change Orders in a timely manner for optimal customer service and business needs.
11. Key stakeholders include but not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer Service, and Manufacturing.
12. Leads and maintains the Layered Process Audit program.
13. Leads Quality Projects related to Document Control and drives projects to completion.
14. Supports management review and all audits/inspections.
15. Maintenance of Quality procedures.
16. Administrates of the Calibration program
17. Assists with CAPAs related to Document Control
18. Assists with internal audit program
19. ISO 13485:2016 & EU-MDR 2017/45 Lead Internal Auditor
20. Drives Continuous Improvement projects
21. Writes, creates, updates, and submits 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 individual 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 a 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.
Qualifications
Skills
Behaviors
:
Motivations
:
Education
Required
Bachelors or better.
Experience
Required
3-5 years:
Quality Management System
Licenses & Certifications
* * *
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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