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.