Director, Digital QA/RA IT Solutions

Olympus Corporation; Center Valley (Lehigh County); Hybrid; USD 145,000 - 217,000; Full time

Benefits offered by this job

Competitive salary

401(k) match

Medical coverage

Paid time off

On-site daycare

Wellbeing programs

Job summary

Olympus Corporation is seeking a Director of IT Solution Owner – QA/RA to lead the global strategy for digital QA/RA solutions, including eQMS and RIM. Collaborate with Quality, Regulatory, R&D, Manufacturing and IT to harmonize processes and drive multi-year roadmaps.

The role focuses on compliance, risk management, lifecycle governance, and delivering business value across QA/RA domains, aligned with Olympus Core Values.

Qualifications

• Bachelor’s degree or equivalent in relevant field.
• Minimum of 10 years’ experience in the assigned business domain.
• Minimum of 7 years’ experience in leadership roles with global scope.
• Deep knowledge of QA/RA processes and regulatory requirements (FDA 21 CFR Parts 11/820, ISO 13485, EU MDR/IVDR).
• Experience in IT solutions delivery, product/platform/project management, and governance.

Responsibilities

• Own the global QA/RA solution portfolio (eQMS, RIM, complaints, CAPA, audits, document control).
• Define strategy, architecture, roadmaps, integrations, and data models.
• Ensure end-to-end traceability, auditability, security, validation, and regulatory compliance.

Skills

Leadership

Strategic thinking

Communication

Regulatory quality domain knowledge

Project management

AI/Automation awareness

Education

Bachelor’s degree in Business, Computer Science, Engineering or equivalent experience

Master’s degree preferred

Tools

eQMS

RIM

PLM

ERP

Job description

Olympus Corporation is seeking a Director of IT Solution Owner – QA/RA to lead the global strategy for digital QA/RA solutions, including eQMS and RIM. Collaborate with Quality, Regulatory, R&D, Manufacturing and IT to harmonize processes and drive multi-year roadmaps.

The role focuses on compliance, risk management, lifecycle governance, and delivering business value across QA/RA domains, aligned with Olympus Core Values.