Job Summary

Ensuring that processes needed for the quality management system are established, implemented, maintained, monitored, and harmonized in an international medical laboratory network setting.

Detailed Job Responsibilities:

• To support country business units of IHH Labs;

1. Development and maintenance of the laboratory quality manuals, laboratory quality procedures manual and associated operations documentation in compliance to ISO 15189 and Collage of American Pathologists quality systems in each business units over network geography.
2. Harmonizing quality management system according to different accreditation standard requirements for all locations.
3. Actively involve “Internal Auditor” training
4. Monitor quality management team members` activity over IHH Labs geography to empower them, to ensure and verify continuity of compliance with policies and procedures applied at IHH Labs business units.

• As a Function Lead of IHH Labs HQR;

1. Ensure the standardization of quality management system. Coordinating continual improvement actions. (PDSA, RCA, 7 Tools, Kaizen…)
2. Built a ”Quality Documents Management System” in order to harmonize critical information retrieve and disseminate the system to all business units.
3. Supervise selection, training, and evaluation of internal auditors of each business unit. Organize and actively manage a supervisory committee to harmonize “internal audit processes” between business units. Develops advisory policies for audit.
4. Actively involve development and maintenance process of metrics to follow and benchmark Quality KPI`s of the business units. Analyze and share data with IHH Labs Management.
5. Organize “IHH Labs Yearly Quality Summit” in collaboration with countries` and headquarter managements.
6. Prepare the schedule for “Periodical Management Review”s of business units and monitors the process, support preparation of yearly report of business units to present IHH Labs top management. Organize “End of Year Management Review” in cooperation with CEO of IHH Labs, present yearly report with detailed “findings” lists to develop next year targets.

Education Requirements:

Basic education requirements: Bachelor's degree in Biomedical Science, Pharmacy, Chemistry orMedicine;

Preferable education requirement: Specialty training on any Medical Laboratory Specialty and MS degree in Quality Management

Skills and Experiences:

• Minimum eight years` experience of Quality Management Responsibility in a Medical Laboratory Network setting.
• Certified experience on ISO 15189, ISO 17025, ISO 19011, ISO 31000, ISO 14001 international standards, and cGMP, CAP, ASHI Accreditation Procedures
• Informed decision making, analytical thinking, strong leadership and development qualities, outstanding quality awareness.
• Organizational planning and problem-solving experiences.
• Building a Quality and Documentation Management system on digital platform, customization of Quality Management workflow for complete laboratory network
• Planning a technical training program for Laboratory; application, certification, and measurement of outcome of the program
• Risk Management
• Building an Environmental Management Framework for laboratory

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.