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Sr. Quality System Engineer

Sr. Quality System Engineer

Waters CorporationTokyo, JP
30+日前
職務内容の詳細

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.
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    Quality Engineer • Tokyo, JP