Quality Manager (CMS229/W)

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Responsibilities:

  • Responsible for the overall Quality department function including supplier quality management, incoming quality control, SPC, in-process control, and outgoing / customer quality assurance;
  • Set quality direction and own quality performance of a sub business unit;
  • Ensure compliance for the implementation and maintenance of quality systems in accordance with ISO 9001, ISO14001, IATF16949, ISO13485 requirements, as well as social responsibility systems in accordance with ISO45001 and SA8000;
  • Responsible for new employees training as well as yearly specialized training based on input from job knowledge coverage survey;
  • Ensure compliance of customer quality & regulatory requirements through effective quality planning and collaboration with customer to establish acceptable and realistic quality criteria as early as during NPI stage;
  • Ensure closer of quality issues through root cause analysis and implementation of effective containment and close-loop corrective/preventive actions;
  • Lead and provide support to cross functional managers to ensure corrective actions / quality continuous improvement occurs per committed time line;
  • Initiate joint continuous improvement program with customer to further improve customer satisfaction;
  • Establish business unit and departmental level quality KPI & target, review and report quality performance regularly to ensure target is achieved;
  • Drive and support quality systems and procedures simplification and standardization projects.

 

Requirements:

  • Minimum 8 years of relevant experience with at least 3 years Quality Management experience in EMS factory environment
  • Written and oral communication skills including ability to understand technical journals, financial reports and legal documents; ability to respond to quality related inquiries or complaints from customers, regulatory agencies; ability to effectively present information to top management and customers;
  • Analytical skills including ability to work with basic mathematical concepts such as probability and statistical inference and applying to practical situations; ability to define problems, collect data, establish facts and draw valid conclusions;
  • Experience in KPI management and medical device quality system with 6 sigma Black or Green belt is an advantage
  • Full understanding of 8D and other problem solving technique;
  • Strong verbal and written communication skills in Mandarin & English;
  • Frequent travel in Dongguan PRC Plant

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