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A leading company in specialty measurement technologies is seeking a Senior Quality Systems Manager to oversee quality and compliance initiatives. This role requires extensive experience in the medical device sector and involves maintaining the Quality Management System, managing audits, and ensuring compliance with global standards. The ideal candidate will have a strong background in regulatory audits and the ability to collaborate with stakeholders.
TheSenior Quality Systems Managerwill lead and oversee quality and compliance initiatives within the region. This role ensures alignment with local regulatory requirements and global quality standards while supporting business operations.
Maintain and enhance theQuality Management System (QMS)to ensure compliance with global and local regulations.
Manageinternal and external audit programsto uphold effectiveness and regulatory adherence.
Oversee thetraining and education program, including Learning Management Systems (LMS), to meet compliance standards.
Ensure products and processes comply withQuality Agreementsbetween regional and global manufacturing entities.
Conductcompliance assessmentsto identify gaps and drive continuous improvement.
Collaborate with leadership to achievecommercial and operational objectives.
Represent the regional team incross-functional, global projectsand initiatives.
Bachelor’s degree inengineering, life sciences, chemistry, or a related field.
10+ yearsof experience in themedical device, diagnostics, or pharmaceutical industry, with5+ years in a managerial role.
Proven experience inleading or supporting regulatory audits(e.g., ISO, health authority inspections).
5+ yearsofQMS Lead Auditorexperience.
Strong understanding ofmedical device regulations and guidelines.
Ability to collaborate effectively withglobal and local stakeholders.
Self-motivated with the ability to work independently in amatrixed organization.
Language proficiency:Native inJapaneseand fluent inEnglish(written and spoken).
A global leader inspecialty measurement technologies, the company has been at the forefront of scientific innovation for over 60 years. With a presence in35+ countries, it serves industries such ashealthcare, environmental science, food safety, and water quality.
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