Role Overview
Olympus Corporation is hiring a principal-level QMS Manager. This is a full-time role in IN. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
Role Overview:
You will be responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations. As the primary Quality lead for an enterprise-wide ERP transformation program, you will partner closely with cross-functional teams to ensure seamless integration of QMS processes into the new ERP platform. Your role will involve ensuring compliance with regulatory standards, driving continuous improvement, and managing changes to existing QMS processes effectively.
Key Responsibilities:
- Serve as the Quality Management Process Owner within the ERP project, ensuring accurate mapping, validation, and integration of quality processes such as nonconformances, CAPA, audits, change control, and document control.
- Translate QMS requirements into ERP functional specifications, collaborate with IT and process teams to design compliant workflows, and lead or support User Requirement Specifications, design reviews, validation protocols, and UAT related to Quality modules.
- 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, and lead harmonization of legacy or site-specific processes into a standardized global model.
- Ensure QMS processes comply with ISO 9001, ISO 13485, FDA 21 CFR Parts 820/11, and other regional requirements, support internal and external audits, and ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.
- Identify improvement opportunities within current QMS processes, deploy scalable, standardized solutions, use data analytics to monitor performance, trends, and compliance metrics, and promote a culture of quality and process excellence across the organization.
- Collaborate with global, regional, and site-level Quality Leaders, provide regular updates to senior leadership, and facilitate cross-functional workshops and working sessions to drive consensus.
Qualifications Required:
- Bachelors degree in engineering, life sciences, Quality, or a related field.
- 510+ years of experience in Quality Management Systems within regulated environments.
- Strong knowledge of QMS processes such as CAPA, NCR, audits, document control, change control, and training.
- Experience supporting or leading ERP Quality modules.
- Demonstrated experience with regulated system validation.
- Business-level proficiency in Japanese is mandatory.
- Ability to work in global working hours, heavy in JST time zone. Role Overview:
You will be responsible for maintaining, enhancing, and harmonizing the Quality Management System across regional and global operations. As the primary Quality lead for an enterprise-wide ERP transformation program, you will partner closely with cross-functional teams to ensure seamless integration of QMS processes into the new ERP platform. Your role will involve ensuring compliance with regulatory standards, driving continuous improvement, and managing changes to existing QMS processes effectively.
Key Responsibilities:
- Serve as the Quality Management Process Owner within the ERP project, ensuring accurate mapping, validation, and integration of quality processes such as nonconformances, CAPA, audits, change control, and document control.
- Translate QMS requirements into ERP functional specifications, collaborate with IT and process teams to design compliant workflows, and lead or support User Requirement Specifications, design reviews, validation protocols, and UAT related to Quality modules.
- 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, and lead harmonization of legacy or site-specific processes into a standardized global model.
- Ensure QMS processes comply with ISO 9001, ISO 13485, FDA 21 CFR Parts 820/11, and other regional requirements, support internal and external audits, and ensure ERP-related process changes are appropriately validated and documented per GxP/GMP requirements.
- Identify improvement opportunities within current QMS processes, deploy scalable, standardized solutions, use data analytics to monitor performance, trends, and compliance metrics, and promote a culture of quality and process excellence across the organization.
- Collaborate with global, regional, and site-level Quality Leaders, provide regular updates to senior leadership, and facilitate cross-functional workshops and working sessions to drive consensus.
Qualifications Required:
- Bachelors degree in engineering, life sciences, Quality, or a related field.
- 510+ years of experience in Quality Management Systems within regulated environments.
- Strong knowledge of QMS processes such as CAPA, NCR, audits, document control, change control, and training.
- Experience supporting or leading ERP Quality modules.
- Demonstrated experience with r
Frequently Asked Questions
How do I apply for the QMS Manager position at Olympus Corporation?
Use the Apply button above to submit your application directly to Olympus Corporation. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the QMS Manager position at Olympus Corporation located?
This position is based in IN. Olympus Corporation has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a QMS Manager at Olympus Corporation earn?
Olympus Corporation has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the QMS Manager role at Olympus Corporation posted?
This role was posted on April 21, 2026 (61 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
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