Vector Laboratories is seeking a Quality Assurance Manager to join our growing team. This role is responsible for all aspects of the development, implementation, and continuous improvement of the Quality Management System, including document/record control, training system, CAPA, design control, supplier management, internal auditing, product release, management review, etc. Ensures compliance with applicable domestic and international standards and regulations.
- Work with various functions, including R&D, manufacturing, QC, customer service, technical support, etc. to develop, implement, and continuously improve the Quality Management System.
- Provide training in ISO requirements and quality procedures.
- Work with quality investigation owners to assess root cause, corrections, corrective actions, preventative actions and effectiveness. Use of quality tools, such as FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Lead the document control function, including document creation, revision, and release of documents. Ensures records are filed and controlled appropriately.
- Reviews and approves batch records for product release.
- Oversee the internal audit program and lead customer audits.
- Work with R&D and custom product management for design control implementation for new and custom products, including defining user needs, risk management, verification and validation, design review requirements, etc.
- Lead the supplier quality management function, including identification of supplier risks and mitigation strategies, supplier qualification, quality agreements, maintain approved vendor list (AVL), etc.
- Maintains monthly quality system metrics, write reports, and conducts quality management reviews as required.
- Work with R&D, operations, commercial, etc. to identify opportunities for improvement. Manage quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
- Supervise subordinate employees, including training, employee development, and performance management.
- Assure compliance with all in-house or external specifications to standards.
- Quality professional with a minimum of 5 years experience in a life science industry and minimum of 3 years in a quality role.
- Requires knowledge of ISO 9001, ISO 13485, 21 CFR 820, or 21 CFR 211.
- Ability to make risk based decisions and effectively communicate risks to management.
- Strong verbal and written communication skills.
- Strong interpersonal skills.
- Strong problem solving skills.
- Self motivated and able to organize and prioritize mulitple tasks.
- Indentify quality issues/discrepancies and effectively resolve discrepancies within the organization.
BS Degree in scientific discipline.