Our client is Medtech Contract Manufacturing Company with Regional sites in Asia.
- Role: The main responsibilities of the Group Quality Director is to formulate and implement the company's quality strategy, quality objectives, quality policies and quality systems, and to be fully responsible for the company's quality management, improve customer satisfaction, and realize the company's operations Strategic objectives.
- Responsibility: Responsible for the formulation of the overall quality policy, overall responsibility for quality management, setting and maintaining quality goals.
- Implement and optimize the quality management system, prepare medium and long-term quality plans, strengthen quality target management, organize personnel to review it to ensure its effective control and operation, and ensure the realization of quality targets and vision.
- Host major quality special meetings, coordinate the cooperation of various departments, and carry out major quality improvement and cost reduction projects.
- Strengthen systematic training on quality tools, concepts and methods such as 6Sigma, improve application capabilities, and promote improved problem-solving timeliness.
- Establish and maintain customer satisfaction goals, review quality control policies, procedures, systems, and operating specifications, and supervise the implementation of quality policies and systems.
- Implement product audits, effectively monitor process quality indicators, promote the improvement and enhancement of process quality, and ensure that products put into production and mass production meet delivery quality targets.
- Effectively promote the improvement of after-sales quality problems and the resolution of customer complaints and improve customer satisfaction.
- Responsible for strengthening and consolidating the firewall (FVMI/CSL1/GP12/IPQC), internally blocking the outflow of defective products, and reducing the company's external quality costs.
- Promote the improvement of quality management capabilities of all employees, organize, plan, and supervise the implementation of improvement education and training, and conduct effect evaluation and verification.
- Regularly provide quality data reports, analysis, and improvements to provide basis for decision-making.
- Carry out the company's safety production tasks and ensure the continuous improvement of 6S conditions within the jurisdiction.
EDUCATION / ACADEMIC QUALIFICATION
- Minimum Degree Holder in Mechanical Engineering and Quality
KEY REQUIRED EXPERIENCE, SKILLS AND ABILITY
- Must have deep knowledge and experience of regulatory requirements for Medical and operational world class standards
- Must have QMS experience for medical device manufacturing
- Knowledge of Automotive Standards and Practices
- Experience as a Lead Auditor
- More than eight years of experience in manufacturing quality overall management.
- Proficient in ISO/TS systems such as FDA21CFR, IATF, VDA6.3, ISO9001, ISO14001, ISO13485, TS16949, etc.
- Proficient in process control/product control/process improvement tools such as SPC, MSA, FMEA, DOE, 6Sigma, etc.
- Familiar with relevant systems and standards of the automotive industry, with good understanding and judgment
- Have strong statistical ability and logical thinking ability, and strong quality analysis and reporting ability.
- Have good internal and external communication and coordination skills.
- Ability to communicate fluently in spoken English.
- Able to accept domestic and overseas business assignments..
- Complete other tasks assigned by superior leaders.
