Job Description

Job Summary: As a member of the company's and global QARA leadership team, the director needs to provide direction and lead the quality, engineering services, facilitiesteam. This position is responsible for driving best-in-class Quality & regulatory Job Summary: As a member of the company's and global QARA leadership team, the director needs to provide direction and lead the quality, engineering services, facilitiesteam. This position is responsible for driving best-in-class Quality & regulatory compliance as well premium product quality. The director creates tactical plans and executes activities in accordance with the local and global procedures to meet the desired outcomes while establishing strong customer relationship. A 'hands-on' leader who establishes a strong team to meet customer demands and optimizes design for manufacturability for quality and custom product lines, and the ability to drive continuous improvement and quality and compliance with 100% on-time delivery and zero defects. Key Duties: 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 FACILITIES & MAINTENANCE Lead facilities and maintenance team to perform the job including directing facilities functions and maintenance functions, implementing policies and safety procedures, engaging with vendors and contractors, minimizing hazards, preparing facilities budgets and monitoring expenditure, designing and planning workstations. Preventive maintenance. Education & Experience : Bachelor's Degree in Engineering Experience in Test Development and process development is an advantage. Requires in depth knowledge of quality system standards such as ISO 13485, ISO 9001, FDA 21 CFR820. Requires experience managing audits from regulators and customer/supplier audits Strategic thinker and resulted driven Strong experience in continuous improvement and capable of driving needed change. Strong business development experience with strong background in medical product and manufacturing processes is required. Experience with quality standards, ISO9001, ISO13485, TL9000, TS16949 At Least 8 years of experience in a leadership roles and leading Engineering/Product Development teams.