Associate Director, Quality - China

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Position Overview

Responsible for all company quality processes in China ensuring compliance to China-specific regulatory requirements. Ensure regulatory compliance to applicable China domestic and international requirements. Integrate activities associated with receiving inspection, in-process inspection, finished product inspection, and product support quality engineering. Work closely with Manufacturing, R&D, Regulatory Affairs, and other Quality Assurance areas to support manufacturing process changes, product design transfers, product sustaining projects, and continuous improvement of product quality. Job duties:

*Must have medical device experience
  • Responsible for all aspects of Quality function related to China.
  • Work very closely with the Regulatory Affairs, China team.
  • Collaborate with Sales and Marketing teams in US and China related to market priorities and timing.
  • Oversee Quality related projects consistent with the company goals.
  • Lead the implementation and maintenance of MV Quality Systems in MV China based facilities.
  • Represent China Quality Assurance on various design and development teams by attending team meetings and providing the required plans, procedures, and regulatory decisions.
  • Advise senior management of action required to meet department objectives.
  • Lead prevention-oriented quality improvement programs to meet company quality goals and objectives.
  • Lead efforts to establish Quality procedures for all stages of product realization compliant to applicable standards.
  • Lead efforts for quality reporting of product-related quality and performance data and apply statistical methods to proactively identify product quality issues and trends. Initiate Corrective and Preventive Actions to ensure product quality and compliance.
  • Review and approve procedures designed to ensure successful testing of critical components, sub-assemblies, and assemblies for conformance to specifications and standards.
  • Remain informed about developments and trends in quality control and make recommendations for appropriate corrective actions.
  • Ensure the quality policy/system is planned, understood, implemented, and maintained within the department.
  • Ensure departmental compliance, as well as appropriate departmental resources, are available to effectively maintain the quality system.
  • Perform additional responsibilities as assigned.

Job Details

    • BA/BS degree in a related field.
    • Must havemedical device experience
    • Fluent (speaking, reading, and writing) in Chinese (Mandarin) and English.
    • A minimum of ten (10) years of professional experience in medical device or quality assurance, including at least three (3) years of experience with China.
    • A minimum of three (3) years of managerial/supervisory responsibility.
    • Strong interpersonal skills with the ability to influence others in a positive and effective manner.
    • Proven analytical abilities and organization skills.
    • Excellent organizational skills and ability to support multiple projects.
    • Excellent written and verbal communication skills, including the ability to communicate on all levels of organization in US and China.
    • Ability to work collaboratively with peers in and outside of the department to achieve goals.
    • Proficient computer skills (e.g., MS Office).
    Desired Qualifications
    • Preferred education/experience areas include clinical, engineering, biological, and regulatory sciences.
    • Master’s degree a plus.
    • Implantable medical devices experience.
    • Ability to work well in a team environment.
    • Detail oriented.
    • Ability to comprehend technical documents and concepts.
    • Ability to achieve accurate and timely results.
    • Intellectual curiosity and an ability to digest and communicate complex technical data.