The role of the QA Manager involves overseeing various aspects of a Quality Management System (QMS) in a regulated environment, particularly for this industry which sits in medical devices and pharmaceuticals. The responsibilities encompass a broad scope, including maintaining quality standards, ensuring compliance with key ISO standards and FDA regulations, managing quality control processes, and leading corrective and preventive actions (CAPA). Here's a breakdown of the key responsibilities:
QMS Effectiveness: Ensuring that the Quality Management System is functioning effectively to meet both internal and external standards. This includes monitoring and improving quality control activities, sterilization procedures, and environmental monitoring.Regulatory Compliance: Ensuring the organization adheres to various ISO standards (e.g., ISO 13485, 11135, 11137, 11607, 14971) and FDA regulations (e.g., 21 CFR Parts 210, 211, 820). These standards and regulations govern various aspects of product development, manufacturing, and quality control processes.QA Staff Supervision: Managing and overseeing the QA team to ensure products are delivered on time while maintaining quality standards. This involves direct supervision of daily activities and performance metrics.Complaint and CAPA Investigations: Leading investigations into customer complaints and non-conformance issues, ensuring that root causes are identified and corrective and preventive actions (CAPA) are implemented to prevent recurrence.Nonconforming Material Process: Overseeing processes related to the handling of nonconforming materials, ensuring that proper controls are in place for the disposition of nonconforming products.Document Review and Approval: Reviewing and approving document changes related to quality control procedures, equipment, and process qualifications, as well as validation protocols and reports.Validation and Qualification: Ensuring that equipment and processes are properly qualified and validated to meet regulatory requirements. This includes overseeing the development and execution of validation protocols and ensuring compliance with relevant standards.Metrics and Reporting: Maintaining key quality performance metrics, ensuring that performance data is collected, analyzed, and reported to drive continuous improvement.Additional Support: Assisting with other tasks as requested by senior management, which could include involvement in audits, training, or other operational activities related to quality assurance.Overall, this QA Manager will play a crucial role in ensuring that the company's products meet regulatory requirements and quality standards, while also driving continuous improvement within the quality assurance process. Education: · Bachelor's Degree in relevant Life Science or other technical discipline Experience: · 5 + years medical device/pharmaceutical experience in a manufacturing environment. · Minimum 5 years expereince in Quality Assurance Operations Management; 2 years in Manufacturing Operations · FDA (CFR 820, 210 and 211), and ISO 13485 systems experience.
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