Director, QA

QUALITY ASSURANCE & REGULATORY COMPLIANCE

• Lead the Quality Team in developing continual quality improvements and ensure implementation and effectiveness of quality system are fulfilling the applicable quality and regulatory and customer requirements
• Assures quality products and processes by establishing and enforcing quality standards and testing materials and products.
• Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures.
• Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures according to applicable regulations and customer requirements
• Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures according to applicable regulations and customer requirements
• Institutes rework standards by devising inspection and physical testing methods and procedures.
• Creates product quality documentation system by writing and updating quality assurance procedures according to applicable regulations and customer requirements
• Maintains product quality and compliance by enforcing quality assurance policies and procedures and government requirements according to applicable standards and regulations. Interfaces with local and government regulatory authorities as required.
• Collaborates with other members of the local and global management to develop new product and engineering designs and manufacturing and training methods.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results.
• Develops a strong quality & regulatory organization by recruiting, selecting, orienting, and training employees on all relevant QARA elements such as:
  • Complaint Handling, CAPA, Auditing, Supplier management, statistical methods……..
• Manages quality assurance staff job results by coaching, counseling, and disciplining employees.
• Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
• Achieves local and global objectives by preparing the quality and regulatory budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Establishes standard operating procedure according to applicable standard for the business and compliance to quality/regulatory requirements