Document Control Manager - 235196 at Medix™ in Lake Geneva, Wisconsin

Job Description:

Position Summary: This role is responsible for managing a team of 1-5 QA Document Control Specialists and overseeing daily operations within Manufacturing Quality Assurance (MQA), Manufacturing Quality Control (MQC), and Documentation Control. Key duties include managing document systems for Quality and Manufacturing/Operations, overseeing document handling, and ensuring GMP/GDP compliance.

Key Responsibilities:

• Manage and process Document Change Requests (DCRs), Batch Records, Device History Records (DHRs), and related quality documents.
• Oversee the operations of the MQA/MQC/Document Control department, ensuring collaboration across departments like Materials Management, Engineering, Validation, Manufacturing, Technical Transfers, and NC/CAPA.
• Evaluate Batch Records, Device History Records, and lab data for approval, release, and disposition.
• Maintain and organize documentation, ensuring compliance with GMP standards and customer expectations.
• Identify testing results, propose corrective actions (CAPA), and ensure proper implementation.
• Support the creation and updates of procedures and records across various functional groups (QA/QC, training, engineering, etc.).
• Ensure all documentation complies with 21 CFR Part 820 and ISO-13485:2016 standards.
• Assist in routine inspections of document control, lab, and manufacturing areas for GMP/GLP compliance.
• Lead project teams to improve MQA QA/QC and document control efficiency.
• Manage and develop staff, providing performance feedback and handling personnel issues.
• Track and report key QA/QC and document control metrics.
• Maintain a compliant library of customer and supplier specifications.
• Assist with Engineering Change Control and notifications to/from customers and suppliers.
• Perform other duties as assigned by the Director of Quality and Regulatory Affairs.
• Be available for off-shift or weekend work to support QC testing as needed.

Position Qualifications:

• Education & Experience:
• BS in science or engineering with 4+ years of medical device or pharmaceutical experience preferred.
• AS with 8+ years of experience, or High School diploma with 10+ years of relevant experience, may also be considered.
• Experience in plastics or military settings is a plus.

Skills & Knowledge:

• Experience in GxP-regulated production processes (GMP/GDP).
• Strong problem-solving and collaboration skills.
• Familiarity with precision measurement tools (e.g., calipers, micrometers, CMM) is advantageous.
• Experience in managing teams and timelines effectively.
• Knowledge of FDA 21 CFR 210-211-820 and ISO 13485 standards.

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