Document Control Specialist II

Document Control Specialist II

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The Document Control Specialist II maintains control of all quality documentation. This position works independently, with minimal supervision, accomplishing daily tasks and advising others. It works closely with all departments to maintain a compliant program. Responsibilities include organizing, maintaining, and updating all controlled documents in compliance with quality system GMP, 21 CFR 820 (FDA), ISO 13485 and other quality standards. The position actively and independently leads projects within established deadlines.

• Promotes a work environment of continuous improvement that supports CQ Medical’s Quality Policy, Quality System, and the appropriate regulations.
• Assists with communicating business related issues or opportunities for improvement to management.
• 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.
• Assists with creating, editing, and proofreading documents.
• Maintains Document Control systems.
• Archives obsolete and historical documents.
• Creates and maintains part numbers and Bill of Materials in ERP/MRP system.
• Monitors training history documentation.
• Works in a team environment to achieve metrics and business goals.
• Collaborates with engineering and other stakeholders to process Engineering Change Orders in a timely manner for optimal customer service and business needs.
• Key stakeholders include but not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer Service, and Manufacturing.
• Leads and maintains the Layered Process Audit program.
• Leads Quality Projects related to Document Control and drives projects to completion.
• Supports management review and all audits/inspections.
• Maintenance of Quality procedures.
• Administrates of the Calibration program.
• Assists with CAPAs related to Document Control.
• Assists with internal audit program.
• ISO 13485:2016 & EU-MDR 2017/45 Lead Internal Auditor.
• Drives Continuous Improvement projects.
• Writes, creates, updates, and submits Quality SOPs, Forms, Templates and other Quality documents for review and approval.
• Remain current on all required training.
• All other job functions as assigned.

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

• 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.

• 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.

• Mid-Senior level

• Full-time

• Administrative

• Medical Equipment Manufacturing

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