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Urgent! Sr. Quality System Engineer Career Opportunity with Waters Corporation in Japan

Sr. Quality System Engineer



Job description

Responsibilities

  • Assist in maintaining and improving the site Quality Management System (QMS) effectiveness and compliance with global and local regulatory (.

    Japan Pharmaceutical Affairs Law) requirements.
  • Help external and internal audits or inspections program to ensure its effectiveness.
  • Recording, analyzing and distributing statistical information of quality affairs.
  • Maintain and improve the site training and education program ie by ensuring an efficient Learning Management Systems (LMS) and meet applicable standards/requirements.
  • Ensure compliance of Waters Japan products and processes with the Quality Agreement between Waters Japan and legal manufacturers.
  • Routinely perform compliance assessments on processes, procedures and regulations to identify potential gaps and implement improvements.
  • Support Japan leadership team to achieve Waters Japan Commercial Operations objectives.
  • Help in representing Waters Japan in regional, global and/or cross functional teams, projects and initiatives.
  • Qualifications

    Education:

    Bachelor's degree in areas such as engineering, life sciences and chemistry.

    Experience:

  • Minimum 5 years of experience in the commercial medical device, diagnostic products or pharmaceutical industry
  • Proven experience in supporting third party audits (ISO registrars, PMDA or other regulatory authorities).
  • QMS auditor experience.
  • Good understanding of PMD Act, relevant regulations and guidelines.
  • Sklll & Competence:

  • Able to collaborate effectively with local and global stakeholders to deliver expected results to Waters.
  • Able to work efficiently with minimum supervision.
  • Able to work within a matrix organization.
  • Languages: Native Japanese, Business English – reading and writing.

  • Required Skill Profession

    Engineers



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