Quality Manager- Medical

Position Summary :

The Quality Manager reports directly to the General Manager or his / her designee and is responsible for all aspects of the Quality and Environmental Management Systems including the development, implementation, maintenance, and management of the quality policies, procedures, processes, programs, and practices that are compliant to the established standards, customer specifications and production goals. The Quality Manager may perform a variety of tasks in accordance with their training, experience, and skill assigned by their Manager includes but not limited to :

Essential Functions and Responsibilities :

• Hire, mentor, and manage the team of Quality Engineers, Quality Supervisors, Quality Inspectors, and / or other staff to meet or exceed all quality control requirements.
• Directly responsible for the creation and maintenance of the Quality Management System that is in full compliance to the existing (and when needed, future) ISO and regulatory standards such as ISO 9001, ISO 13485, ISO 14001, and / or FDA etc.
• Lead a variety of external audits (customer, notified body, FDA, fire department etc.), as and when needed, and address / close all findings successfully.
• Creates strong quality control environment, a key go-to figure for all quality related topics / issues. Responsible for managing and maintaining the Quality Control program in the plant with zero defect mindset. Applies quality management tools and approaches to analytically identify, report, and resolve quality issues.
• Develop and analyze statistical data and process specifications to determine yields and to establish quality of in-process and finished products. Provide technical and statistical expertise to teams as and when needed.
• Identify, drive and maintain quality control goals and ongoing quality control objectives; coordinate with Operations and Manufacturing departments to maximize product quality and minimize costs.
• Interfaces with the Corporate Quality Group for escalations, procedures, reporting, quality tools, etc.Take responsibility to drive periodic quality review meetings and take ownership to improve yields at all stages of quality control and quality assurance on the Production floor. Prepare and present Management Reviews as mandated by the company QMS.
• Drive CAPA program, help internal / external teams to drive true root cause analysis and corrective actions to eradicate the issues permanently.
• Responsible for managing the MRB and RMA programs to keep them below the established targets at all time with zero-waste mindset. Oversee Calibration Programs, ESD Control , NCMR Control, regular Internal Audits, and all other areas and programs relevant to a robust quality control system.
• Interface customers to represent company for the internal as well as the external quality failures.
• Manage and maintain the Environmental Health and Safety program. Closely work with Corporate managers to fulfill environment, health, and safety requirements.
• Drive sustainability projects under the guidance from the Corporate directives and cover the plant in corporate as well as customer audits.
• Drive to maintain continuous improvement for the organization that include Kaizen projects, Gemba walks, and 5S disciplines.
• May be responsible for owning and maintaining the Document Control that include the full management and control of the customer, quality, and production documents.
• Other relevant tasks as assigned.

Qualifications Required :

Available to work the days and hours necessary to perform all assigned responsibilities and tasks. Must be available (especially during regular business hours or shifts) to communicate with other employees, supervisors, customers, vendors, and any other person or organization with whom interaction is required to accomplish work and goals. This may include odd hour teleconferences with global facilities.

Mathematical Skills :

Reasoning Ability :

Physical Demands and Work Environment :

The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to sit, stand and / or walk for extended periods of time; use hands and fingers to handle panels and boards; reach with hands and arms; and talk and hear. The employee must occasionally lift and / or move up to 30 pounds and have steady hands and dexterity. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Decision Making Authority :

Financial Responsibility :