QMS Manager/Engineer (Expert)

■PURPOSE/SUMMARY

The QMS Manager/Engineer is responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations while serving as the primary Quality lead for an enterprise-wide ERP transformation program. This role partners closely with cross functional teams including IT, Supply Chain, Manufacturing, Engineering, Regulatory, and Quality to ensure that all QMS processes, documentation, and data structures integrate seamlessly into the new ERP platform. The individual ensures compliance with applicable regulatory standards, drives continuous improvement, and effectively manages change to existing QMS processes.

■PRIMARY DUTIES AND RESPONSIBILITIES

ERP Project Support (Primary Responsibility)

・Serve as the Quality Management Process Owner within the ERP project, ensuring that quality processes (e.g., nonconformances, CAPA, audits, change control, document control) are accurately mapped, validated, and integrated.

・Translate QMS requirements into ERP functional specifications; collaborate with IT and process teams to design compliant workflows.

・Lead or support User Requirement Specifications (URS), design reviews, validation protocols, and UAT related to Quality modules.

・Ensure ERP configuration aligns with global QMS policies, regulatory requirements, and industry standards.

・Identify and mitigate quality related risks tied to system migration, master data, document migration, and process harmonization.

・Support global training development for Quality modules and deliver training as required.

Global & Regional QMS Governance

・Maintain and improve global QMS processes, procedures, and documentation.

・Act as a change owner or reviewer for QMS process updates triggered by ERP transformation or business needs.

・Lead harmonization of legacy or site-specific processes into a standardized global model.

・Ensure regional sites adopt and sustain updated QMS processes and tools.

・Monitor compliance readiness and partner with sites to close gaps identified during audits or process reviews.

Compliance and Regulatory Alignment

・Ensure QMS processes comply with ISO 9001, ISO 13485 (if applicable), FDA 21 CFR Parts 820/11, and other regional requirements.

・Support internal and external audits by acting as subject matter expert on process and system changes.

・Ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.

Continuous Improvement

・Identify improvement opportunities within current QMS processes and help deploy scalable, standardized solutions.

・Use data analytics from ERP and QMS tools to monitor performance, trends, and compliance metrics.

・Promote a culture of quality and process excellence across the organization.

Stakeholder Engagement

・Collaborate with global, regional, and site-level Quality Leaders to align priorities and rollout plans.

・Provide regular updates to senior leadership on implementation progress, risks, and mitigation strategies.

・Facilitate cross-functional workshops and working sessions to drive consensus.

■COMPETENCIES

・Ability to translate business needs into system/process requirements.

・Excellent problem solving and analytical skills.

・Strong project management and stakeholder management capability.

・Adaptability in managing both strategic and tactical responsibilities.

・High attention to detail and compliance mindset.

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■MINIMUM QUALIFICATIONS

Required

・Bachelor’s degree in engineering, life sciences, Quality, or related field.

・5-10+ years of experience in Quality Management Systems within manufacturing, medical devices, pharmaceuticals, biotech, industrials, or similar regulated environments.

・Strong knowledge of QMS processes (CAPA, NCR, audits, document control, change control, training, complaints).

・Experience supporting or leading ERP Quality modules (SAP, Oracle, Microsoft Dynamics, Infor, etc.).

・Demonstrated experience with regulated system validation (CSV / GxP / Part 11).

・Strong cross-functional leadership and communication skills.

・Fluency in English and Japanese

・Ability to work in global working hours, heavy in JST time zone

・Ability to travel internationally as needed

Preferred

・Experience in a global, multi-site organization.

・Certification(s): ASQ CQE/CQA, ISO Auditor/Lead Auditor.

・Experience harmonizing or implementing global QMS systems.

・Lean/Six Sigma certifications.

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【Employment type】

Regular full-time employee (3-month probationary period; no change to terms and conditions during probation)

Working hours

8:45-17:30 (break: 45 minutes)

Standard working hours: 8 hours

Flextime system available / no core time (not applicable if hired as a manager)

Reduced-hours work system, telework, and overtime work available

Working hours may be changed depending on business needs

【Holidays & leave】

Annual holidays: 129 days (according to company calendar)

Paid leave: 20 days of annual paid leave granted

For other systems and details, please see: https://www.olympus.co.jp/csr/social/inclusion/japan/?page=csr https://www.olympus.co.jp/csr/social/health-management/?page=csr

【Allowances / programs】

Commuting allowance, work-from-home allowance, etc.

Social insurance provided (employment insurance, health insurance, welfare pension, long-term care insurance, workers’ compensation insurance)

Defined benefit corporate pension, defined contribution pension

【Welfare benefits】

The listed welfare benefits are subject to various rules and conditions.

For details, please see: https://www.olympus.co.jp/recruit/workstyle/benefit/ https://www.olympus.co.jp/csr/social/health-management/?page=csr