Medix
Document Control Manager
Medix, Lake Geneva, Wisconsin, United States, 53147
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.
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.