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Associate Director, Quality - China

Company: MicroVention-Terumo
Location: Aliso Viejo
Posted on: August 6, 2022

Job Description:

Associate Director, Quality - ChinaResponsible 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. What You'll Be Doing

  • 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.The Skills/Experience Needed for the Job
    • BA/BS degree in a related field.
    • Must have medical 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).What Will Differentiate You From the Crowd
      • 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.We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

Keywords: MicroVention-Terumo, Aliso Viejo , Associate Director, Quality - China, Executive , Aliso Viejo, California

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