Responsible for the organization, administration, and control of all quality assurance functions. Responsibilities include outgoing quality, safety, and efficacy of all material and finished products manufactured; and for overall compliance with all applicable regulations. Additionally, the incumbent ensures that a quality system is established, implemented, and maintained in accordance with standards; and reporting on the performance of the quality system to the CEO for review and as a basis for improvement to the quality system.
To establish, implement and maintain the Quality Management System / Frame work.
To Develop the quality vision, mission, systems and processes needed to support overall Strategy goals;
To ensure compliance of quality plan for manufacturing and quality control operations as per agreed contractual requirement / acceptance criteria with the customer, SOP’s, Good Manufacturing Practices/Quality System Regulations (QSR) and other applicable standards and regulations;
To issue a “QA veto” to the Production Manager or the Project Manager (with copy to the top management) if there is a major non conformity in the product / process quality.
To submit the periodic appraisal reports of the quality department to HR/Admin.
To submit the weekly / monthly / quarterly reports of the quality department to GM.
To prepare and submit the Yearly Department Budget and for controlling within the approved limits.
To proactively advise management on status, risk, and recommend improvements to quality to ensure customer satisfaction;
To develop, lead and execute long-term and short-term quality strategies and plans to ensure sustainable results that meet or exceed the company’s financial and operational targets;
To build, align and create synergies cross-functionally to drive internal and external quality improvement;
Lead the development of processes and systems to align the Quality Division with business objectives to drive operational excellence;
To manage the quality staff, Develop and maintain training and development programs as appropriate for various levels in the organization. Maintain technical skill levels within quality to meet the needs of manufacturing and quality engineering needs. Interact with other department heads and functions as required;
To plan, develop and manage programs that monitor, predict, or regulate the manufacturing process using appropriate auditing, testing, and statistical process control strategies;
To represent the company as the primary contact during Federal/Military inspections. Provide information as necessary to the appropriate authorities that establishes credibility and demonstrates compliance with QSR's;
To ensure all incoming materials and finished product meet specifications for release to be used by production and that a program for supplier qualification and approval is in place;
To validate the newly procured equipment, processes, systems, and facility changes that impact quality;
To Maintain a calibration program for all equipment and measuring devices used in the manufacturing, testing and control of subassemblies and finished goods as well as support systems;
To Review, approve, and maintain all documentation required for batch and system records for identification and traceability. Release product for distribution to customer;
To evaluate and solve product and process problems by providing technical, analytical and managerial skills;
To ensure compliance with regulatory agency and corporate requirements through a formal self-audit program;
To initiate action to prevent the occurrence of any nonconformities relating to product, process, and quality system (by identifying and recording any problems relating to the product, process and quality system) initiating, recommending, or providing solutions through designated channels;
Verifying the implementation of solutions and corrective and preventive actions taken;
Controlling further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
To Keep historical information of all sold products (lot, raw materials, tests, QC, QA….tests)
Responsible for the staffing and directing the HSE Department, including the management of all Safety representatives.
Responsible for the development of an annual budget recommendations and implementation.
Directs the resources and activities to support the OSHE programs.
Review and finalize internal OSHE policies and practices to ensure they are current and appropriate; conduct hazard and risk assessments and change existing, or develop new recommendations from these assessments.
Act as Management Representative for OSHAD
OSH Roles and Responsibilities:
allocate responsibility for OSH management and delegation of authorities;
ensure adequate budget and resources for OSH management;
ensure appropriate OSH supervision of employees;
implement and monitor effectiveness of risk management program(s);
ensure appropriate hazard and incident investigations;
regularly discuss OSH issues at meetings of departments, divisions or senior management;
ensure provision of OSH information, training and supervision; and
ensure appropriate emergency procedures are developed.